HIV Infections
Conditions
Brief summary
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).
Detailed description
This study compared the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) with rilpivirine (RPV) LA and cabotegravir (CAB) LA versus all-oral standard of care (SOC). As the study was originally designed, the study included four steps. Step 1, Induction Previously non-adherent individuals were enrolled and underwent a period (up to 24 weeks) of induction SOC ART regimen using conditional economic incentives (CEI). Participants who achieved virologic suppression criteria at or after Step 1, week 4, defined as: a) HIV-1 RNA ≤200 copies/mL or b) HIV-1 RNA of 201-399 copies/mL followed by HIV-1 RNA ≤200 copies/mL by Step 1, week 24, were eligible to enter Step 2. Step 2, Randomization Eligible participants were randomized at Step 2 entry in a 1:1 ratio to either of the two treatment arms: Arm A (LA ART): A combination of oral RPV + oral CAB for 4 weeks (optional) followed by the LA ART Phase, consisting of a two-drug regimen using RPV-LA + CAB-LA Q4 weeks until the end of Step 2 (Table 5.2.1-2). The option to initiate LA ART at the Step 2 Randomization visit without oral RPV + oral CAB was at the discretion of the site investigator of Record (IoR) and participant (see section 2.1, Direct-to-Inject). Arm B (SOC): Continuation of the SOC for 52 weeks. Step 3, Continuation/Crossover Arm A participants continued on RPV-LA + CAB-LA Q4 weeks for 52 weeks until the end of Step 3. Arm B participants (continuation of SOC) who achieved virologic suppression (HIV-1 RNA ≤200 copies/mL) at Step 2, week 48, or HIV-1 RNA of 201-399 copies/mL at Step 2, week 48, followed by HIV-1 RNA ≤200 copies/mL by Step 2, week 52, had the option to cross over at the end of Step 2 to oral RPV + oral CAB for 4 weeks (optional) followed by RPV-LA + CAB-LA every 4 weeks until the end of Step 3 (Table 5.2.1-3). Arm B participants who did not wish or were not eligible to cross over completed study follow-up at Step 2, week 52. If RPV-LA + CAB-LA became available before a participant finished Step 3, and the participant chose to continue RPV-LA + CAB-LA as part of their clinical care, their follow-up in the study ended at the completion of Step 3. If for some reason the participant chose not to continue LA ART at the end of Step 3 or if LA ART was not available, the participant registered to Step 4 and was followed on locally sourced oral ARV for 52 weeks. Step 4, Observation Participants who registered to Step 4 were followed for up to 52 weeks on oral ART. In addition, any participant who received at least one dose of CAB-LA or RPV-LA at any step, and prematurely discontinued the LA ART prior to the end of Step 3, completed their respective Step (either Step 2 or 3) on study/off study treatment, and registered to Step 4 and were followed to complete 52 weeks total on oral ART after their last dose of any LA injectable. If LA ART became available during follow-up in Step 4, and the participant and provider decided to restart LA ART, they were allowed to do so. In that case, the participants were not followed by the study after restarting LA ART. On February 12, 2024, based on the interim efficacy results, Data Safety and Monitoring Board (DSMB) recommended stopping randomization to Step 2 and transitioning all eligible participants in Steps 1 and 2 to LA-ART. Per recommendations from DSMB, randomization into Step 2 stopped on February 16, 2024, leaving three steps in the current study protocol 4.0: In Step 1, participants will receive a SOC oral induction regimen consisting of an ART regimen that involves at least 3 drugs for 24 weeks. Participants who achieve milestones will receive conditional economic incentives. With randomization into Step 2 ended, all eligible Step 1 participants will register to Step 3 at the completion of Step 1. Participants who are currently on Step 2: Eligible participants in Step 2 Arm A (already on RPV-LA + CAB-LA) will register to Step 3 and continue on this regimen until the end of Step 3 (52 weeks; See protocol for more information). This should happen at the next scheduled study visit after approval of Version 4.0. Eligible participants in Step 2 Arm B (SOC arm) will register to Step 3 and switch to oral RPV + oral CAB for 4 weeks (optional; see protocol for more information) followed by RPV-LA + CAB-LA Q4 weeks until the end of Step 3 (52 weeks). This should happen at the next scheduled study visit after approval of Version 4.0. Eligible participants will enter Step 4 and be followed up to 52 weeks on locally sourced oral ART. Participants will be followed for up to a total of 180 weeks. Study visits, which will occur throughout the study, may include physical examinations; blood, urine, and hair collection; liver function tests; questionnaires; and an electrocardiogram (ECG). NOTE: Data summarized in the primary analysis report were based on evaluations undertaken at visits conducted prior to the implementation of Protocol v4.0 which incorporated February 12, 2024 DSMB recommendations. Primary analyses were outlined in the A5359 primary Statistical Analysis Plan (SAP) version 6.0 (dated August 5, 2024) focusing on follow-up in Step 1 and Step 2.
Interventions
DRUGStandard of Care (SOC) Oral ART
SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)
DRUGOral RPV
RPV 25 mg tablets
DRUGOral CAB
CAB 30 mg tablets
DRUGRPV-LA Loading Dose
900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle
DRUGCAB-LA Loading Dose
600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
DRUGRPV-LA Maintenance Dose
600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle
DRUGCAB-LA Maintenance Dose
400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle
Sponsors
ViiV Healthcare
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Step 1 Inclusion Criteria HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load. NOTE: The term licensed referred to an FDA-approved kit, which was required for all IND studies. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandated that confirmation of the initial test result had to use a test that was different from the one used for the initial assessment. A reactive initial rapid test had to be confirmed by either another type of rapid assay or an E/CIA that was based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load. HIV-1 Plasma viral load (VL) greater than 200 copies/mL within 12 months prior to study entry by any US laboratory that had a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, unless the participant had been lost to clinical follow-up (see protocol for more information) and no viral load result was available within the last 12 months. NOTE: Participants who satisfied non-adherence eligibility due to loss to clinical follow-up might not have had a viral load result available at the time of consideration for eligibility. Those participants could be screened and, regardless of their screening viral load result (either ≤ or \>200 copies/mL), they would have been eligible for study entry if they met all other inclusion/
Exclusion criteria
. Evidence of non-adherence to ART according to at least one of the following criteria: Poor virologic response within 18 months prior to study entry (defined as less than 1 log10 decrease in HIV-1 RNA or HIV-1 RNA greater than 200 copies/mL at two time points at least 4 weeks apart) in individuals who had been prescribed ART for at least 6 consecutive months. Lost to clinical follow-up within 18 months prior to study entry with ART non-adherence for greater than or equal to 6 consecutive months. NOTE: Lost to clinical follow-up was defined as either no contact with the provider or missing greater than or equal to 1 appointment in a 6-month period. ART non-adherence was defined as a lapse in ART greater than or equal to 7 days (consecutive or non-consecutive), in the 6-month period where they were lost to clinical follow-up per participant report. No evidence of any clinically relevant RPV or INSTI resistance-associated mutations (see protocol for more information) through commercially available genotypic (or phenotypic, if available) analyses from any laboratory that had a CLIA certification or equivalent within 60 days of study entry (see protocol for more information), nor history of such mutations on review of prior HIV-1 drug resistance tests by the site investigator. For participants in whom a screening HIV-1 conventional genotype could not be resulted by the testing laboratory, review of historical genotypes and treatment history by the IoR could be used to satisfy this criterion as indicated in the protocol. Ability of site clinician, in conjunction with the participant, to construct an oral induction antiretroviral (ARV) regimen that had to include at least three ARVs of which at least two had to be predicted to be fully active. The regimen had to include PI/cobi and/or an INSTI based on screening and/or historic resistance testing. Laboratory values obtained within 60 days prior to study entry by any laboratory that had a CLIA certification or its equivalent: Hemoglobin greater than or equal to 9.0 g/dL Absolute neutrophil count (ANC) greater than or equal to 600/mm\^3 Alanine aminotransferase (ALT) less than or equal to 3 x upper limit of normal (ULN) Creatinine Clearance (CrCl) greater than or equal to 50 mL/min estimated by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-Epi). For participants of reproductive potential, a negative serum or urine pregnancy test with a sensitivity of less than or equal to 25 mIU/mL at screening. This was repeated again at study entry. NOTE: Participants were considered to be NOT of reproductive potential if: 1) they had had amenorrhea for at least 12 consecutive months prior to study entry (i.e., who had had no menses within 12 months prior to study entry), and had a documented follicle-stimulating hormone (FSH) greater than 40 IU/mL; OR 2) an FSH level was not available, but they had had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR 3) they reported having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion). Contraception Requirements Participants of Reproductive Potential: Participants of reproductive potential, who were participating in sexual activity that could lead to pregnancy, had to agree to use at least one of the listed highly effective methods for contraception from 30 days prior to the first dose of study medication, while receiving the study drugs, and for 30 days after stopping oral medications, or the duration specified in the product label if receiving study drugs not supplied by the study, or 52 weeks after stopping RPV-LA or CAB-LA. Acceptable methods of contraception included: Contraceptive subdermal implant Intrauterine device or intrauterine system Combined estrogen and progestogen oral contraceptive Injectable progestogen Contraceptive vaginal ring Percutaneous contraceptive patches Participants Who Were Not of Reproductive Potential: Participants who were not of reproductive potential were eligible to start study drugs without requiring the use of contraceptives. Any statement of self-reported sterility or that of her partner's had to be entered in the source documents. NOTE A: Acceptable documentation of lack of reproductive potential was the participant's self-reported history of surgical sterilization, menopause, or male partner's azoospermia. NOTE B: ALL participants in the study were to be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to a partner without HIV. Ability and willingness of participant or legal guardian/representative to provide written informed consent. Step 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Probability of Regimen Failure in Step 2 at Any Time Post Randomization and Week 48 Visit | From Step 2 randomization to Step 2, Week 48 visit (up to 50 weeks) | Regimen failure was defined as the occurrence of the earlier of the following two events * virologic failure (defined as two consecutive HIV-1 RNA \>200 copies/mL after Step 2 randomization * Permanent discontinuation of randomized study treatment prior to or at Week 48 visit Cumulative probability was calculated by Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Probability of Virologic Failure in Step 2 at Any Time Post Randomization to Week 48 Visit | From Step 2 randomization to Step 2, Week 48 visit (up to 50 weeks) | Virologic failure was defined as two consecutive HIV-1 RNA \>200 copies/mL after Step 2 randomization and up to Step 2 Week 48 visit, regardless of the time between them. Cumulative probability was calculated by Kaplan-Meier method. |
| Cumulative Probability of the Treatment-related Failure in Step 2 at Any Time Post Randomization to Week 48 Visit | From after Step 2 randomization to Step 2, Week 48 (up to 50 weeks) | Treatment-related failure was defined as the occurrence of the earlier of virologic failure or permanent Step 2 treatment discontinuation due to treatment-related adverse events. Cumulative probability was calculated by Kaplan-Meier method. |
| Number of Participants With Virologic Non-success (>= 50 Copies/ml) | from Step 2 randomization to Step 2, Week 48 (up to 50 weeks) | Virologic non-success was defined by the US Food and Drug Administration (FDA) Snapshot algorithm |
| Number of Participants With Virologic Non-success (>= 200 Copies/ml) | From Step 2 randomization to Step 2, Week 48 (up to 50 weeks) | Virologic non-success was defined by the US Food and Drug Administration (FDA) Snapshot algorithm |
| Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Measured from Step 1 entry through Step 1, Week 20 visit | Summarized the percentage of participants with plasma HIV-1 RNA level less than 50 copies/mL by study visit |
| Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Measured from Step 1 entry through Step 1, Week 20 visit | Summarized the percentage of participants with plasma HIV-1 RNA level less than 200 copies/mL by study visit |
| Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Measured from Step 2 entry through Step 2, Week 48 visit | Summarized the percentage of participants with plasma HIV-1 RNA level less than 50 copies/mL by study visit, and randomized treatment. |
| Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Measured from Step 2 entry through Step 2, Week 48 visit | Summarized the percentage of participants with plasma HIV-1 RNA level less than 200 copies/mL by study visit, and randomized treatment. |
| Cumulative Probability of Discontinuation of Randomized Treatment in Step 2 | Measured from Step 2 randomization through Step 2, Week 48 (up to 50 weeks) | Permanent Step 2 treatment discontinuation was defined as premature discontinuation of randomized study treatment. Cumulative probability was calculated by Kaplan-Meier method. |
| Number of Participants With Missed or Delayed Injections for Participants Who Received LA ART in Step 2 | Measured from Step 2 randomization through Step 2, Week 52 | Delayed injection was defined as 36-56 days from the previous injection. Missed injection was defined as the duration from the previous injection was longer than 56 days. |
| Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 1 | Step 1 entry, Weeks 12 and 20. | HIV Treatment Adherence Self-Efficacy Scale was a 12-item measure used to measure social and psychological determinants of adherence to ART among individuals living with HIV. The response scale to each individual item ranged from 0 (cannot do at all) to 10 (completely certain can do). The total score reported was the average of all item scores, ranging from 0 to 10, with higher scores indicating higher adherence self-efficacy. |
| Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | As Step 2 Week 0, Week 24 and Week 48 | HIV Treatment Adherence Self-Efficacy Scale was a 12-item measure used to measure social and psychological determinants of adherence to ART among individuals living with HIV. The response scale to each individual item ranged from 0 (cannot do at all) to 10 (completely certain can do). The total score reported was the average of all item scores, ranging from 0 to 10, with higher scores indicating higher adherence self-efficacy. |
| Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Measured at Step 1 screening/entry and at the time of virologic failure in Step 2 | Samples for HIV-1 resistance testing were collected at virologic failure confirmation visit. HIV-1 drug resistance mutations were determined using the IAS October/November 2022 Update of the Drug Resistance Mutations in HIV-1. New drug resistance mutations were defined as those detected at or after virologic failure which were not present at Step 1 screening/baseline. Virologic failure defined as two consecutive HIV-1 RNA \> 200 copies/mL after Step 2 randomization, regardless of the time between them. |
| Percentage of Participants With Grade 1 or Higher Injection Site Reactions (ISR) During Step 2 | Measured from Step 2 randomization through Step 2, Week 52 | Summarized and tabulated by number of participants with at least 1 injection site reactions. Severity Grade: 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Life-Threatening, 5 = Death |
| Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit | Step 2 week 48, premature treatment visit, and study discontinuation visit | The Dichotomous Preference Questionnaire were: 1. Monthly injections of Long-Acting HIV Treatment 2. Daily oral HIV |
| Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | At Step 2 entry and Step 2, Week 8 | The responses included: Not at all upset or disappointed, Not very upset or disappointed, Somewhat upset or disappointed, Extremely upset or disappointed, Undecided |
| Median of Average Total Score of Step 1 HIV Treatment Adherence Self-Efficacy Scale Score (HIV-ASES) | Step 1 entry, Step 1 Weeks 12, and Step 1 Weeks 20 | HIV-ASES was a 12-item measure used to measure social and psychological determinants of adherence to ART among individuals living with HIV. The response scale to each individual item ranged from 0 (cannot do at all) to 10 (completely certain can do). The total score reported was the average of all item scores, ranging from 0 to 10, with higher scores indicating higher adherence self-efficacy. |
| Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | At Step 2 entry, Step 2 week 4, Step 2 week 8, step 2 week 16, step 2 week 24, step 2 week 36, Step 2 week 48, and Step 2 week 52 | The outcome was defined as participants with at least one dose missed in the last 30 days at each visit |
| Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status was collected on both arms at Step 2 entry and Week 24, and also at Week 48 for those randomized to SOC. At Week 48, HIVTSQ change was collected for participants on the LA-ART arm. | The questionnaire had 12 items rated using a 7-point Likert scale. Results were summarized as a total score that included 11 items, with the pain/discomfort item reported separately. 1. The HIVTSQ status measured participant satisfaction with their current treatment with individual item rated ranging from 0 (very dissatisfied) to 6 (very satisfied) and the total score ranging from 0 to 66, where higher scores indicated a greater level of satisfaction with their HIV-1 treatment. 2. The HIVTSQ change measured change in treatment satisfaction between a participant's previous and current treatment. The individual items were rated from -3 (much less satisfied) to 3 (much more satisfied) with a total score ranging from -33 to 33. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled at 33 Clinical Research Sites (CRSs) in the United States between March 28, 2019 and February 12, 2024. A total of 456 participants enrolled to study. After completing Step 1, 308 participants were randomized to Step 2. Enrollment to Step 3 and Step 4 will be updated upon study completion.
Pre-assignment details
Step 1 eligibility violations were identified in three participants. One participant was found to have missed the screening confirmatory HBV DNA test. Two participants were found to have past exclusionary mutations after enrolled to Step 2. All three participants were excluded from all analyses. 453 eligible participants were enrolled to Step 1. 306 eligible participants were randomized to Step 2 after completing Step 1.
Participants by arm
| Arm | Count |
|---|---|
| Step 1 SOC In Step 1, participants received SOC oral ART regimen for up to 24 weeks. | 453 |
| Step 2 Arm A: LA-ART In Step 2, participants received oral RPV once daily and oral CAB once daily for 4 weeks (optional), followed by a RPV-LA loading dose and a CAB-LA loading dose, followed in 4 weeks by an RPV-LA maintenance dose and a CAB-LA maintenance dose every 4 weeks for 44 weeks. | 152 |
| Step 2 Arm B: SOC In Step 2, participants received SOC oral ART regimen for 52 weeks. | 154 |
| Total | 759 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Step 1 | Death | 1 | 0 | 0 |
| Step 1 | Lost to Follow-up | 31 | 0 | 0 |
| Step 1 | On Step 1 as of February 12, 2024 | 27 | 0 | 0 |
| Step 1 | Other reasons | 12 | 0 | 0 |
| Step 1 | Pregnancy | 1 | 0 | 0 |
| Step 1 | Protocol Violation | 8 | 0 | 0 |
| Step 1 | Withdrawal by Subject | 13 | 0 | 0 |
| Step 2 | Confounding Medical Condition | 0 | 0 | 1 |
| Step 2 | Death | 0 | 2 | 0 |
| Step 2 | Incarceration | 0 | 2 | 0 |
| Step 2 | Lost to Follow-up | 0 | 8 | 15 |
| Step 2 | Non-Compliance With Study Requirements | 0 | 1 | 1 |
| Step 2 | On Step 2 as of February 12, 2024 | 0 | 56 | 56 |
| Step 2 | Out Of State With No Plan To Return | 0 | 1 | 0 |
| Step 2 | Switched To Injectables | 0 | 0 | 1 |
| Step 2 | Withdrawal by Subject | 0 | 6 | 6 |
Baseline characteristics
| Characteristic | Step 1 SOC | Total | Step 2 Arm A: LA-ART | Step 2 Arm B: SOC |
|---|---|---|---|---|
| Age, Continuous Step 1 | 40 years | 40 years | — | — |
| Age, Continuous Step 2 | — | 42 years | 41 years | 42 years |
| Age, Customized Step 1 18-24 | 29 Participants | 29 Participants | — | — |
| Age, Customized Step 1 25-30 | 64 Participants | 64 Participants | — | — |
| Age, Customized Step 1 31-40 | 142 Participants | 142 Participants | — | — |
| Age, Customized Step 1 41-50 | 102 Participants | 102 Participants | — | — |
| Age, Customized Step 1 51+ | 116 Participants | 116 Participants | — | — |
| Age, Customized Step 2 18-24 | — | 15 Participants | 8 Participants | 7 Participants |
| Age, Customized Step 2 25-30 | — | 41 Participants | 21 Participants | 20 Participants |
| Age, Customized Step 2 31-40 | — | 86 Participants | 46 Participants | 40 Participants |
| Age, Customized Step 2 41-50 | — | 72 Participants | 27 Participants | 45 Participants |
| Age, Customized Step 2 51+ | — | 92 Participants | 50 Participants | 42 Participants |
| AUDIT-C Alcohol Consumption Score Step 1 | 2 score | 2 score | — | — |
| AUDIT-C Alcohol Consumption Score Step 2 | — | 2 score | 2 score | 2 score |
| Average Yearly Household Income Step 1 $10000 - 19999 | 99 Participants | 99 Participants | — | — |
| Average Yearly Household Income Step 1 $20000 - 29999 | 54 Participants | 54 Participants | — | — |
| Average Yearly Household Income Step 1 $30000 - 39999 | 45 Participants | 45 Participants | — | — |
| Average Yearly Household Income Step 1 $40000 - 49999 | 28 Participants | 28 Participants | — | — |
| Average Yearly Household Income Step 1 $50000 or more per year | 26 Participants | 26 Participants | — | — |
| Average Yearly Household Income Step 1 $5000 - 9999 | 59 Participants | 59 Participants | — | — |
| Average Yearly Household Income Step 1 Less than $5000 per year | 128 Participants | 128 Participants | — | — |
| Average Yearly Household Income Step 1 Missing | 14 Participants | 14 Participants | — | — |
| Average Yearly Household Income Step 2 $10000 - 19999 | — | 63 Participants | 32 Participants | 31 Participants |
| Average Yearly Household Income Step 2 $20000 - 29999 | — | 33 Participants | 17 Participants | 16 Participants |
| Average Yearly Household Income Step 2 $30000 - 39999 | — | 33 Participants | 18 Participants | 15 Participants |
| Average Yearly Household Income Step 2 $40000 - 49999 | — | 12 Participants | 8 Participants | 4 Participants |
| Average Yearly Household Income Step 2 $50000 or more per year | — | 24 Participants | 8 Participants | 16 Participants |
| Average Yearly Household Income Step 2 $5000 - 9999 | — | 46 Participants | 24 Participants | 22 Participants |
| Average Yearly Household Income Step 2 Less than $5000 per year | — | 89 Participants | 42 Participants | 47 Participants |
| Average Yearly Household Income Step 2 Missing | — | 6 Participants | 3 Participants | 3 Participants |
| BMI, continuous Step 1 | 26 kg/m² | 26 kg/m² | — | — |
| BMI, continuous Step 2 | — | 26 kg/m² | 27 kg/m² | 26 kg/m² |
| CD4, continuous Step 1 | 273 cells/mm^3 | 273 cells/mm^3 | — | — |
| CD4, continuous Step 2 | — | 389 cells/mm^3 | 417 cells/mm^3 | 379 cells/mm^3 |
| CD8, continuous Step 1 | 843 cells/mm^3 | 843 cells/mm^3 | — | — |
| CD8, continuous Step 2 | — | 861 cells/mm^3 | 846 cells/mm^3 | 866 cells/mm^3 |
| Drug Dependency Step 1 Drug Dependency | 23 Participants | 23 Participants | — | — |
| Drug Dependency Step 1 Drug-Use-Related Problems | 205 Participants | 205 Participants | — | — |
| Drug Dependency Step 1 Missing | 1 Participants | 1 Participants | — | — |
| Drug Dependency Step 1 No Drug Problems | 224 Participants | 224 Participants | — | — |
| Drug Dependency Step 2 Drug Dependency | — | 14 Participants | 7 Participants | 7 Participants |
| Drug Dependency Step 2 Drug-Use-Related Problems | — | 133 Participants | 69 Participants | 64 Participants |
| Drug Dependency Step 2 Missing | — | 0 Participants | 0 Participants | 0 Participants |
| Drug Dependency Step 2 No Drug Problems | — | 159 Participants | 76 Participants | 83 Participants |
| Education Level Step 1 11th grade or less | 89 Participants | 89 Participants | — | — |
| Education Level Step 1 College graduate (BA or BS) | 40 Participants | 40 Participants | — | — |
| Education Level Step 1 Doctorate/medical degree/law degree | 6 Participants | 6 Participants | — | — |
| Education Level Step 1 High school graduate or GED | 141 Participants | 141 Participants | — | — |
| Education Level Step 1 Master's degree | 6 Participants | 6 Participants | — | — |
| Education Level Step 1 Missing | 9 Participants | 9 Participants | — | — |
| Education Level Step 1 Some college/AA degree/Technical school training | 162 Participants | 162 Participants | — | — |
| Education Level Step 2 11th grade or less | — | 59 Participants | 32 Participants | 27 Participants |
| Education Level Step 2 College graduate (BA or BS) | — | 24 Participants | 11 Participants | 13 Participants |
| Education Level Step 2 Doctorate/medical degree/law degree | — | 5 Participants | 2 Participants | 3 Participants |
| Education Level Step 2 High school graduate or GED | — | 95 Participants | 47 Participants | 48 Participants |
| Education Level Step 2 Master's degree | — | 6 Participants | 1 Participants | 5 Participants |
| Education Level Step 2 Missing | — | 9 Participants | 5 Participants | 4 Participants |
| Education Level Step 2 Some college/AA degree/Technical school training | — | 108 Participants | 54 Participants | 54 Participants |
| Employment or School Step 1 Full-time employment | 117 Participants | 117 Participants | — | — |
| Employment or School Step 1 Full-time student | 13 Participants | 13 Participants | — | — |
| Employment or School Step 1 Missing | 5 Participants | 5 Participants | — | — |
| Employment or School Step 1 On disability | 96 Participants | 96 Participants | — | — |
| Employment or School Step 1 OTHER | 147 Participants | 147 Participants | — | — |
| Employment or School Step 1 Part-time employment | 61 Participants | 61 Participants | — | — |
| Employment or School Step 1 Part-time student | 3 Participants | 3 Participants | — | — |
| Employment or School Step 1 Pension/Retired | 11 Participants | 11 Participants | — | — |
| Employment or School Step 2 Full-time employment | — | 94 Participants | 45 Participants | 49 Participants |
| Employment or School Step 2 Full-time student | — | 5 Participants | 3 Participants | 2 Participants |
| Employment or School Step 2 Missing | — | 6 Participants | 3 Participants | 3 Participants |
| Employment or School Step 2 On disability | — | 63 Participants | 28 Participants | 35 Participants |
| Employment or School Step 2 OTHER | — | 87 Participants | 43 Participants | 44 Participants |
| Employment or School Step 2 Part-time employment | — | 40 Participants | 23 Participants | 17 Participants |
| Employment or School Step 2 Part-time student | — | 2 Participants | 1 Participants | 1 Participants |
| Employment or School Step 2 Pension/Retired | — | 9 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Step 1 Hispanic or Latino | 79 Participants | 79 Participants | — | — |
| Ethnicity (NIH/OMB) Step 1 Not Hispanic or Latino | 369 Participants | 369 Participants | — | — |
| Ethnicity (NIH/OMB) Step 1 Unknown or Not Reported | 5 Participants | 5 Participants | — | — |
| Ethnicity (NIH/OMB) Step 2 Hispanic or Latino | — | 55 Participants | 29 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Step 2 Not Hispanic or Latino | — | 246 Participants | 121 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Step 2 Unknown or Not Reported | — | 5 Participants | 2 Participants | 3 Participants |
| General Anxiety Disorder (GAD-7) Step 1 Mild [5-<10] | 106 Participants | 106 Participants | — | — |
| General Anxiety Disorder (GAD-7) Step 1 Missing | 3 Participants | 3 Participants | — | — |
| General Anxiety Disorder (GAD-7) Step 1 Moderate [10-<15] | 56 Participants | 56 Participants | — | — |
| General Anxiety Disorder (GAD-7) Step 1 No Anxiety [<5] | 228 Participants | 228 Participants | — | — |
| General Anxiety Disorder (GAD-7) Step 1 Severe Anxiety [15+] | 60 Participants | 60 Participants | — | — |
| General Anxiety Disorder (GAD-7) Step 2 Mild [5-<10] | — | 84 Participants | 38 Participants | 46 Participants |
| General Anxiety Disorder (GAD-7) Step 2 Missing | — | 0 Participants | 0 Participants | 0 Participants |
| General Anxiety Disorder (GAD-7) Step 2 Moderate [10-<15] | — | 40 Participants | 18 Participants | 22 Participants |
| General Anxiety Disorder (GAD-7) Step 2 No Anxiety [<5] | — | 160 Participants | 84 Participants | 76 Participants |
| General Anxiety Disorder (GAD-7) Step 2 Severe Anxiety [15+] | — | 22 Participants | 12 Participants | 10 Participants |
| History of IV drug use Step 1 Currently | 20 Participants | 20 Participants | — | — |
| History of IV drug use Step 1 Never | 390 Participants | 390 Participants | — | — |
| History of IV drug use Step 1 Previously | 43 Participants | 43 Participants | — | — |
| History of IV drug use Step 2 Currently | — | 12 Participants | 8 Participants | 4 Participants |
| History of IV drug use Step 2 Never | — | 267 Participants | 129 Participants | 138 Participants |
| History of IV drug use Step 2 Previously | — | 27 Participants | 15 Participants | 12 Participants |
| HIV-1 RNA levels, categorical Step 1 >10,000 | 123 Participants | 123 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 1,001-5,000 | 48 Participants | 48 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 201-399 | 16 Participants | 16 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 400-1,000 | 28 Participants | 28 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 <50 | 85 Participants | 85 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 5,001-10,000 | 22 Participants | 22 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 50-200 | 69 Participants | 69 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 Missing | 4 Participants | 4 Participants | — | — |
| HIV-1 RNA levels, categorical Step 1 Not done | 58 Participants | 58 Participants | — | — |
| HIV-1 RNA levels, categorical Step 2 >10,000 | — | 9 Participants | 8 Participants | 1 Participants |
| HIV-1 RNA levels, categorical Step 2 1,001-5,000 | — | 8 Participants | 6 Participants | 2 Participants |
| HIV-1 RNA levels, categorical Step 2 201-399 | — | 8 Participants | 5 Participants | 3 Participants |
| HIV-1 RNA levels, categorical Step 2 400-1,000 | — | 7 Participants | 4 Participants | 3 Participants |
| HIV-1 RNA levels, categorical Step 2 <50 | — | 231 Participants | 108 Participants | 123 Participants |
| HIV-1 RNA levels, categorical Step 2 5,001-10,000 | — | 2 Participants | 1 Participants | 1 Participants |
| HIV-1 RNA levels, categorical Step 2 50-200 | — | 37 Participants | 18 Participants | 19 Participants |
| HIV-1 RNA levels, categorical Step 2 Missing | — | 1 Participants | 0 Participants | 1 Participants |
| HIV-1 RNA levels, categorical Step 2 Not done | — | 3 Participants | 2 Participants | 1 Participants |
| How to Pay Healthcare Step 1 Government Funding | 350 Participants | 350 Participants | — | — |
| How to Pay Healthcare Step 1 Government Funding, Private Insurance | 15 Participants | 15 Participants | — | — |
| How to Pay Healthcare Step 1 Government Funding, Private Insurance, Self Pay/Out of Pocket | 3 Participants | 3 Participants | — | — |
| How to Pay Healthcare Step 1 Government Funding, Self Pay/Out of Pocket | 20 Participants | 20 Participants | — | — |
| How to Pay Healthcare Step 1 Missing | 20 Participants | 20 Participants | — | — |
| How to Pay Healthcare Step 1 Private Insurance | 30 Participants | 30 Participants | — | — |
| How to Pay Healthcare Step 1 Private Insurance, Self Pay/Out of Pocket | 3 Participants | 3 Participants | — | — |
| How to Pay Healthcare Step 1 Self Pay/Out of Pocket | 12 Participants | 12 Participants | — | — |
| How to Pay Healthcare Step 2 Government Funding | — | 229 Participants | 117 Participants | 112 Participants |
| How to Pay Healthcare Step 2 Government Funding, Private Insurance | — | 14 Participants | 4 Participants | 10 Participants |
| How to Pay Healthcare Step 2 Government Funding, Private Insurance, Self Pay/Out of Pocket | — | 4 Participants | 2 Participants | 2 Participants |
| How to Pay Healthcare Step 2 Government Funding, Self Pay/Out of Pocket | — | 11 Participants | 7 Participants | 4 Participants |
| How to Pay Healthcare Step 2 Missing | — | 15 Participants | 8 Participants | 7 Participants |
| How to Pay Healthcare Step 2 Private Insurance | — | 20 Participants | 8 Participants | 12 Participants |
| How to Pay Healthcare Step 2 Private Insurance, Self Pay/Out of Pocket | — | 2 Participants | 0 Participants | 2 Participants |
| How to Pay Healthcare Step 2 Self Pay/Out of Pocket | — | 11 Participants | 6 Participants | 5 Participants |
| Living Situation Step 1 At Parents House | 64 Participants | 64 Participants | — | — |
| Living Situation Step 1 In Own House/Apartment | 270 Participants | 270 Participants | — | — |
| Living Situation Step 1 Missing | 9 Participants | 9 Participants | — | — |
| Living Situation Step 1 On The Street(S) | 9 Participants | 9 Participants | — | — |
| Living Situation Step 1 Other | 11 Participants | 11 Participants | — | — |
| Living Situation Step 1 Residential Drug/Alcohol Treatment Facility | 1 Participants | 1 Participants | — | — |
| Living Situation Step 1 Rooming Boarding Or Halfway House | 17 Participants | 17 Participants | — | — |
| Living Situation Step 1 Shelter/Welfare Hotel | 15 Participants | 15 Participants | — | — |
| Living Situation Step 1 Someone Else House/Apartment | 57 Participants | 57 Participants | — | — |
| Living Situation Step 2 At Parents House | — | 36 Participants | 15 Participants | 21 Participants |
| Living Situation Step 2 In Own House/Apartment | — | 200 Participants | 101 Participants | 99 Participants |
| Living Situation Step 2 Missing | — | 4 Participants | 2 Participants | 2 Participants |
| Living Situation Step 2 On The Street(S) | — | 4 Participants | 1 Participants | 3 Participants |
| Living Situation Step 2 Other | — | 4 Participants | 2 Participants | 2 Participants |
| Living Situation Step 2 Residential Drug/Alcohol Treatment Facility | — | 2 Participants | 2 Participants | 0 Participants |
| Living Situation Step 2 Rooming Boarding Or Halfway House | — | 6 Participants | 1 Participants | 5 Participants |
| Living Situation Step 2 Shelter/Welfare Hotel | — | 9 Participants | 3 Participants | 6 Participants |
| Living Situation Step 2 Someone Else House/Apartment | — | 41 Participants | 25 Participants | 16 Participants |
| Non-Adherence information Step 1 Lost to follow-up | 93 Participants | 93 Participants | — | — |
| Non-Adherence information Step 1 Poor virologic response | 294 Participants | 294 Participants | — | — |
| Non-Adherence information Step 1 Poor virologic response and lost to follow-up | 66 Participants | 66 Participants | — | — |
| Non-Adherence information Step 2 Lost to follow-up | — | 70 Participants | 33 Participants | 37 Participants |
| Non-Adherence information Step 2 Poor virologic response | — | 194 Participants | 99 Participants | 95 Participants |
| Non-Adherence information Step 2 Poor virologic response and lost to follow-up | — | 42 Participants | 20 Participants | 22 Participants |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 1 Mild Depression [5-9] | 106 Participants | 106 Participants | — | — |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 1 Missing | 3 Participants | 3 Participants | — | — |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 1 Moderate Depression [10-14] | 56 Participants | 56 Participants | — | — |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 1 No Depression [0-4] | 228 Participants | 228 Participants | — | — |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 1 Severe Depression [15-27] | 60 Participants | 60 Participants | — | — |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 2 Mild Depression [5-9] | — | 64 Participants | 29 Participants | 35 Participants |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 2 Missing | — | 0 Participants | 0 Participants | 0 Participants |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 2 Moderate Depression [10-14] | — | 44 Participants | 24 Participants | 20 Participants |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 2 No Depression [0-4] | — | 174 Participants | 85 Participants | 89 Participants |
| Participant Health Questionnaire (PHQ-9) total score [0-27] Step 2 Severe Depression [15-27] | — | 24 Participants | 14 Participants | 10 Participants |
| Provide Support to Friend/Family Member Step 1 Missing | 5 Participants | 5 Participants | — | — |
| Provide Support to Friend/Family Member Step 1 No | 332 Participants | 332 Participants | — | — |
| Provide Support to Friend/Family Member Step 1 Yes | 116 Participants | 116 Participants | — | — |
| Provide Support to Friend/Family Member Step 2 Missing | — | 4 Participants | 2 Participants | 2 Participants |
| Provide Support to Friend/Family Member Step 2 No | — | 221 Participants | 109 Participants | 112 Participants |
| Provide Support to Friend/Family Member Step 2 Yes | — | 81 Participants | 41 Participants | 40 Participants |
| Race (NIH/OMB) Step 1 American Indian or Alaska Native | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Step 1 Asian | 3 Participants | 3 Participants | — | — |
| Race (NIH/OMB) Step 1 Black or African American | 286 Participants | 286 Participants | — | — |
| Race (NIH/OMB) Step 1 More than one race | 11 Participants | 11 Participants | 0 Participants | — |
| Race (NIH/OMB) Step 1 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Step 1 Unknown or Not Reported | 28 Participants | 28 Participants | 0 Participants | — |
| Race (NIH/OMB) Step 1 White | 125 Participants | 125 Participants | — | — |
| Race (NIH/OMB) Step 2 American Indian or Alaska Native | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Step 2 Asian | — | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Step 2 Black or African American | — | 197 Participants | 94 Participants | 103 Participants |
| Race (NIH/OMB) Step 2 More than one race | — | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Step 2 Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Step 2 Unknown or Not Reported | — | 21 Participants | 9 Participants | 12 Participants |
| Race (NIH/OMB) Step 2 White | — | 80 Participants | 44 Participants | 36 Participants |
| Sex: Female, Male Step 1 Female | 133 Participants | 133 Participants | — | — |
| Sex: Female, Male Step 1 Male | 320 Participants | 320 Participants | — | — |
| Sex: Female, Male Step 2 Female | — | 84 Participants | 43 Participants | 41 Participants |
| Sex: Female, Male Step 2 Male | — | 222 Participants | 109 Participants | 113 Participants |
| Smoke Status Step 1 CUREENT | 220 Participants | 220 Participants | — | — |
| Smoke Status Step 1 FORMER | 89 Participants | 89 Participants | — | — |
| Smoke Status Step 1 Missing | 1 Participants | 1 Participants | — | — |
| Smoke Status Step 1 NEVER | 143 Participants | 143 Participants | — | — |
| Smoke Status Step 2 CUREENT | — | 141 Participants | 78 Participants | 63 Participants |
| Smoke Status Step 2 FORMER | — | 61 Participants | 27 Participants | 34 Participants |
| Smoke Status Step 2 Missing | — | 0 Participants | 0 Participants | 0 Participants |
| Smoke Status Step 2 NEVER | — | 104 Participants | 47 Participants | 57 Participants |
| Step 1 HIV-1 RNA, continuous | 3.45 log10 copies/mL | 3.45 log10 copies/mL | — | — |
| Step 2 HIV-1 RNA levels, categorical ≤200 | — | 268 Participants | 126 Participants | 142 Participants |
| Step 2 HIV-1 RNA levels, categorical >200 | — | 34 Participants | 24 Participants | 10 Participants |
| Step 2 HIV-1 RNA levels, categorical Missing | — | 1 Participants | 0 Participants | 1 Participants |
| Step 2 HIV-1 RNA levels, categorical Not done | — | 3 Participants | 2 Participants | 1 Participants |
| Suicide Severity Rating Step 1 High Risk | 10 Participants | 10 Participants | — | — |
| Suicide Severity Rating Step 1 Low Risk | 31 Participants | 31 Participants | — | — |
| Suicide Severity Rating Step 1 Missing | 9 Participants | 9 Participants | — | — |
| Suicide Severity Rating Step 1 Moderate Risk | 45 Participants | 45 Participants | — | — |
| Suicide Severity Rating Step 1 No Risk | 358 Participants | 358 Participants | — | — |
| Suicide Severity Rating Step 2 High Risk | — | 2 Participants | 1 Participants | 1 Participants |
| Suicide Severity Rating Step 2 Low Risk | — | 19 Participants | 12 Participants | 7 Participants |
| Suicide Severity Rating Step 2 Missing | — | 4 Participants | 0 Participants | 4 Participants |
| Suicide Severity Rating Step 2 Moderate Risk | — | 27 Participants | 14 Participants | 13 Participants |
| Suicide Severity Rating Step 2 No Risk | — | 254 Participants | 125 Participants | 129 Participants |
| Time since HIV diagnosis Step 1 | 13 years | 13 years | — | — |
| Time since HIV diagnosis Step 2 | — | 13 years | 13 years | 12 years |
| Treated for Depression or Mental Health Step 1 Missing | 6 Participants | 6 Participants | — | — |
| Treated for Depression or Mental Health Step 1 No | 323 Participants | 323 Participants | — | — |
| Treated for Depression or Mental Health Step 1 Yes | 124 Participants | 124 Participants | — | — |
| Treated for Depression or Mental Health Step 2 Missing | — | 4 Participants | 2 Participants | 2 Participants |
| Treated for Depression or Mental Health Step 2 No | — | 225 Participants | 109 Participants | 116 Participants |
| Treated for Depression or Mental Health Step 2 Yes | — | 77 Participants | 41 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 453 | 2 / 152 | 0 / 154 |
| other Total, other adverse events | 73 / 453 | 40 / 152 | 37 / 154 |
| serious Total, serious adverse events | 38 / 453 | 21 / 152 | 16 / 154 |
Outcome results
Primary
Cumulative Probability of Regimen Failure in Step 2 at Any Time Post Randomization and Week 48 Visit
Regimen failure was defined as the occurrence of the earlier of the following two events * virologic failure (defined as two consecutive HIV-1 RNA \>200 copies/mL after Step 2 randomization * Permanent discontinuation of randomized study treatment prior to or at Week 48 visit Cumulative probability was calculated by Kaplan-Meier method.
Time frame: From Step 2 randomization to Step 2, Week 48 visit (up to 50 weeks)
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Step 2 Arm A: LA ART | Cumulative Probability of Regimen Failure in Step 2 at Any Time Post Randomization and Week 48 Visit | 22.8 cumulative percent probability of event |
| Step 2 Arm B: SOC | Cumulative Probability of Regimen Failure in Step 2 at Any Time Post Randomization and Week 48 Visit | 41.2 cumulative percent probability of event |
Comparison: Treatment comparison was conducted by cumulative probability of regimen failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.98.4% CI: [-32.4, -4.3]
Secondary
Cumulative Probability of Discontinuation of Randomized Treatment in Step 2
Permanent Step 2 treatment discontinuation was defined as premature discontinuation of randomized study treatment. Cumulative probability was calculated by Kaplan-Meier method.
Time frame: Measured from Step 2 randomization through Step 2, Week 48 (up to 50 weeks)
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Step 2 Arm A: LA ART | Cumulative Probability of Discontinuation of Randomized Treatment in Step 2 | 19.8 cumulative percent probability of event |
| Step 2 Arm B: SOC | Cumulative Probability of Discontinuation of Randomized Treatment in Step 2 | 28.2 cumulative percent probability of event |
Comparison: Treatment comparison was conducted by cumulative probability of permanent treatment discontinuation in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.98.4% CI: [-21.3, 4.5]
Secondary
Cumulative Probability of the Treatment-related Failure in Step 2 at Any Time Post Randomization to Week 48 Visit
Treatment-related failure was defined as the occurrence of the earlier of virologic failure or permanent Step 2 treatment discontinuation due to treatment-related adverse events. Cumulative probability was calculated by Kaplan-Meier method.
Time frame: From after Step 2 randomization to Step 2, Week 48 (up to 50 weeks)
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Step 2 Arm A: LA ART | Cumulative Probability of the Treatment-related Failure in Step 2 at Any Time Post Randomization to Week 48 Visit | 8.9 cumulative percent probability of event |
| Step 2 Arm B: SOC | Cumulative Probability of the Treatment-related Failure in Step 2 at Any Time Post Randomization to Week 48 Visit | 28.1 cumulative percent probability of event |
Comparison: Treatment comparison was conducted by cumulative probability of treatment-related failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.98.4% CI: [-31.6, -6.9]
Secondary
Cumulative Probability of Virologic Failure in Step 2 at Any Time Post Randomization to Week 48 Visit
Virologic failure was defined as two consecutive HIV-1 RNA \>200 copies/mL after Step 2 randomization and up to Step 2 Week 48 visit, regardless of the time between them. Cumulative probability was calculated by Kaplan-Meier method.
Time frame: From Step 2 randomization to Step 2, Week 48 visit (up to 50 weeks)
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Step 2 Arm A: LA ART | Cumulative Probability of Virologic Failure in Step 2 at Any Time Post Randomization to Week 48 Visit | 6.8 cumulative percent probability of event |
| Step 2 Arm B: SOC | Cumulative Probability of Virologic Failure in Step 2 at Any Time Post Randomization to Week 48 Visit | 28.2 cumulative percent probability of event |
Comparison: Treatment comparison was conducted by cumulative probability of virologic failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.98.4% CI: [-33.5, -9.3]
Secondary
Median of Average Total Score of Step 1 HIV Treatment Adherence Self-Efficacy Scale Score (HIV-ASES)
HIV-ASES was a 12-item measure used to measure social and psychological determinants of adherence to ART among individuals living with HIV. The response scale to each individual item ranged from 0 (cannot do at all) to 10 (completely certain can do). The total score reported was the average of all item scores, ranging from 0 to 10, with higher scores indicating higher adherence self-efficacy.
Time frame: Step 1 entry, Step 1 Weeks 12, and Step 1 Weeks 20
Population: Step 1 used Intention-to-Treat (ITT) population which was defined as all eligible participants who registered to Step 1, regardless of status on treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Median of Average Total Score of Step 1 HIV Treatment Adherence Self-Efficacy Scale Score (HIV-ASES) | Week 0 | 9 score on a scale |
| Step 2 Arm A: LA ART | Median of Average Total Score of Step 1 HIV Treatment Adherence Self-Efficacy Scale Score (HIV-ASES) | Week 12 | 9 score on a scale |
| Step 2 Arm A: LA ART | Median of Average Total Score of Step 1 HIV Treatment Adherence Self-Efficacy Scale Score (HIV-ASES) | Week 20 | 9 score on a scale |
Secondary
Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 1
HIV Treatment Adherence Self-Efficacy Scale was a 12-item measure used to measure social and psychological determinants of adherence to ART among individuals living with HIV. The response scale to each individual item ranged from 0 (cannot do at all) to 10 (completely certain can do). The total score reported was the average of all item scores, ranging from 0 to 10, with higher scores indicating higher adherence self-efficacy.
Time frame: Step 1 entry, Weeks 12 and 20.
Population: Step 1 used Intention-to-Treat (ITT) population which was defined as all eligible participants who registered to Step 1, regardless of status on treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 1 | Week 0 | 9 score on a scale |
| Step 2 Arm A: LA ART | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 1 | Week 12 | 9 score on a scale |
| Step 2 Arm A: LA ART | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 1 | Week 20 | 9 score on a scale |
Secondary
Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2
HIV Treatment Adherence Self-Efficacy Scale was a 12-item measure used to measure social and psychological determinants of adherence to ART among individuals living with HIV. The response scale to each individual item ranged from 0 (cannot do at all) to 10 (completely certain can do). The total score reported was the average of all item scores, ranging from 0 to 10, with higher scores indicating higher adherence self-efficacy.
Time frame: As Step 2 Week 0, Week 24 and Week 48
Population: As-treated Population was defined as all eligible participants who were randomized to the treatment arms and received at least one dose of a randomized treatment. Participants were assessed according to actual treatment strategy received.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | Week 0 | 9 score on a scale |
| Step 2 Arm A: LA ART | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | Week 24 | 10 score on a scale |
| Step 2 Arm A: LA ART | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | Week 48 | 10 score on a scale |
| Step 2 Arm B: SOC | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | Week 0 | 9 score on a scale |
| Step 2 Arm B: SOC | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | Week 24 | 10 score on a scale |
| Step 2 Arm B: SOC | Median of Summary Scores of HIV Treatment Adherence Self-Efficacy Scale in Step 2 | Week 48 | 10 score on a scale |
Secondary
Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2
The questionnaire had 12 items rated using a 7-point Likert scale. Results were summarized as a total score that included 11 items, with the pain/discomfort item reported separately. 1. The HIVTSQ status measured participant satisfaction with their current treatment with individual item rated ranging from 0 (very dissatisfied) to 6 (very satisfied) and the total score ranging from 0 to 66, where higher scores indicated a greater level of satisfaction with their HIV-1 treatment. 2. The HIVTSQ change measured change in treatment satisfaction between a participant's previous and current treatment. The individual items were rated from -3 (much less satisfied) to 3 (much more satisfied) with a total score ranging from -33 to 33.
Time frame: HIVTSQ status was collected on both arms at Step 2 entry and Week 24, and also at Week 48 for those randomized to SOC. At Week 48, HIVTSQ change was collected for participants on the LA-ART arm.
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received. Data were not collected from participants for HIVTSQ status for participants in LA-ART arm at week 24 or HIVTSQ change for participants in SOC arm at week 48
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 0, 11-item total score | 63 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 0, Satisfaction with pain/discomfort | 6 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 24, 11-item total score | 66 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 24, Satisfaction with pain/discomfort | 6 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ change Week 24, 11-item total score | 0 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ change Week 24, Satisfaction with pain/discomfort | 0 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ change Week 48,11-item total score | 33 score on a scale |
| Step 2 Arm A: LA ART | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ change Week 48, Satisfaction with pain/discomfort | 3 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 48,11-item total score | 63 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 0, 11-item total score | 62 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 48, Satisfaction with pain/discomfort | 6 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 0, Satisfaction with pain/discomfort | 6 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ change Week 24, Satisfaction with pain/discomfort | 0 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 24, 11-item total score | 62 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ change Week 24, 11-item total score | 0 score on a scale |
| Step 2 Arm B: SOC | Median Summary Score of HIV Treatment Satisfaction Questionnaire (HIVTSQ) in Step 2 | HIVTSQ status Week 24, Satisfaction with pain/discomfort | 6 score on a scale |
Secondary
Number of Participants With Missed or Delayed Injections for Participants Who Received LA ART in Step 2
Delayed injection was defined as 36-56 days from the previous injection. Missed injection was defined as the duration from the previous injection was longer than 56 days.
Time frame: Measured from Step 2 randomization through Step 2, Week 52
Population: Analysis population was restricted to the participants who initiated injections
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Number of Participants With Missed or Delayed Injections for Participants Who Received LA ART in Step 2 | Delayed injection | 32 participants |
| Step 2 Arm A: LA ART | Number of Participants With Missed or Delayed Injections for Participants Who Received LA ART in Step 2 | Missed injection | 15 participants |
Secondary
Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2
Samples for HIV-1 resistance testing were collected at virologic failure confirmation visit. HIV-1 drug resistance mutations were determined using the IAS October/November 2022 Update of the Drug Resistance Mutations in HIV-1. New drug resistance mutations were defined as those detected at or after virologic failure which were not present at Step 1 screening/baseline. Virologic failure defined as two consecutive HIV-1 RNA \> 200 copies/mL after Step 2 randomization, regardless of the time between them.
Time frame: Measured at Step 1 screening/entry and at the time of virologic failure in Step 2
Population: Analysis population was restricted to the participants with virologic failure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Without New Mutation | 3 Participants |
| Step 2 Arm A: LA ART | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Not done; HIV-1 RNA < 400 copies/mL | 1 Participants |
| Step 2 Arm A: LA ART | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Discontinued study without a confirmation sample | 0 Participants |
| Step 2 Arm A: LA ART | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Sample Not Collected | 0 Participants |
| Step 2 Arm A: LA ART | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | With New Mutation | 2 Participants |
| Step 2 Arm B: SOC | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Sample Not Collected | 3 Participants |
| Step 2 Arm B: SOC | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | With New Mutation | 2 Participants |
| Step 2 Arm B: SOC | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Without New Mutation | 20 Participants |
| Step 2 Arm B: SOC | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Discontinued study without a confirmation sample | 5 Participants |
| Step 2 Arm B: SOC | Number of Participants With New Drug-resistance Mutations in Participants With Virologic Failure in Step 2 | Not done; HIV-1 RNA < 400 copies/mL | 4 Participants |
Secondary
Number of Participants With Virologic Non-success (>= 200 Copies/ml)
Virologic non-success was defined by the US Food and Drug Administration (FDA) Snapshot algorithm
Time frame: From Step 2 randomization to Step 2, Week 48 (up to 50 weeks)
Population: The analysis population was restricted to participants randomized at least 50 weeks prior to February 12, 2024.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | HIV-1 RNA >= 200 copies/ml | 5 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | Treatment Discontinuation due to other reasons with HIV-1 RNA < 200 copies/ml | 12 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | Treatment Discontinuation due to AE or Death | 6 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | On treatment but missing data | 2 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | HIV-1 RNA < 200 copies/ml | 69 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | On treatment but missing data | 1 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | HIV-1 RNA < 200 copies/ml | 55 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | HIV-1 RNA >= 200 copies/ml | 25 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | Treatment Discontinuation due to AE or Death | 0 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 200 Copies/ml) | Treatment Discontinuation due to other reasons with HIV-1 RNA < 200 copies/ml | 15 Participants |
Comparison: The proportions of participants with HIV-1 RNA ≥ 200 copies/ml was compared by Fisher's Exact Test.p-value: <0.00195% CI: [-36.1, -12.8]Fisher Exact
Secondary
Number of Participants With Virologic Non-success (>= 50 Copies/ml)
Virologic non-success was defined by the US Food and Drug Administration (FDA) Snapshot algorithm
Time frame: from Step 2 randomization to Step 2, Week 48 (up to 50 weeks)
Population: The analysis population was restricted to participants randomized at least 50 weeks prior to February 12, 2024.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | HIV-1 RNA >= 50 copies/ml | 14 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | Treatment Discontinuation due to other reasons with HIV-1 RNA < 50 copies/ml | 10 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | Treatment Discontinuation due to AE or Death | 6 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | On treatment but missing data | 2 Participants |
| Step 2 Arm A: LA ART | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | HIV-1 RNA < 50 copies/ml | 62 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | On treatment but missing data | 1 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | HIV-1 RNA < 50 copies/ml | 49 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | HIV-1 RNA >= 50 copies/ml | 33 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | Treatment Discontinuation due to AE or Death | 0 Participants |
| Step 2 Arm B: SOC | Number of Participants With Virologic Non-success (>= 50 Copies/ml) | Treatment Discontinuation due to other reasons with HIV-1 RNA < 50 copies/ml | 13 Participants |
p-value: <0.00195% CI: [-35.6, -8.1]Fisher Exact
Secondary
Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit
The Dichotomous Preference Questionnaire were: 1. Monthly injections of Long-Acting HIV Treatment 2. Daily oral HIV
Time frame: Step 2 week 48, premature treatment visit, and study discontinuation visit
Population: Analysis population was restricted to the participants who had the indicated visit, either week 48, premature treatment discontinuation, or premature study discontinuation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit | At Week 48, Daily oral HIV Treatment | 5 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit | At Week 48, Monthly injections of Long-Acting HIV Treatment | 95 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit | At Premature treatment discontinuation, Daily oral HIV Treatment | 50 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit | At Premature treatment discontinuation, Monthly injections | 50 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants Who Preferred Monthly Injections of Long-Acting HIV Treatment or Daily Oral HIV Treatment at Each Visit | At Premature study discontinuation, Monthly injections | 100 percentage of participants |
Secondary
Percentage of Participants With Grade 1 or Higher Injection Site Reactions (ISR) During Step 2
Summarized and tabulated by number of participants with at least 1 injection site reactions. Severity Grade: 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Life-Threatening, 5 = Death
Time frame: Measured from Step 2 randomization through Step 2, Week 52
Population: Analysis population was restricted to participants who initiated injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Grade 1 or Higher Injection Site Reactions (ISR) During Step 2 | 60 percentage of participant |
Secondary
Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2
The outcome was defined as participants with at least one dose missed in the last 30 days at each visit
Time frame: At Step 2 entry, Step 2 week 4, Step 2 week 8, step 2 week 16, step 2 week 24, step 2 week 36, Step 2 week 48, and Step 2 week 52
Population: As-treated Population was defined as all eligible participants who were randomized to the treatment arms and received at least one dose of a randomized treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 0 | 57 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 4 | 59 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 8 | 62 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 16 | 64 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 24 | 64 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 36 | 66 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 48 | 66 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Missed Treatment Doses Among Participants Who Randomized to SOC Arm in Step 2 | Week 52 | 59 percentage of participants |
Secondary
Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal
The responses included: Not at all upset or disappointed, Not very upset or disappointed, Somewhat upset or disappointed, Extremely upset or disappointed, Undecided
Time frame: At Step 2 entry and Step 2, Week 8
Population: Modified Intention-to-Treat (mITT) Population was defined as all eligible participants who were randomized to the treatment arms and received at least one dose of study treatment at or after randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Not at all upset or disappointed | 48 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Not very upset or disappointed | 13 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Somewhat upset or Week 0, disappointed | 18 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Extremely upset or disappointed | 11 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Undecided | 9 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Not at all upset or disappointed | 43 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Not very upset or disappointed | 16 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Somewhat upset or disappointed | 24 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Extremely upset or disappointed | 12 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Undecided | 5 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Somewhat upset or disappointed | 23 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Not at all upset or disappointed | 49 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Not at all upset or disappointed | 37 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Not very upset or disappointed | 9 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Undecided | 10 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Somewhat upset or Week 0, disappointed | 18 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Not very upset or disappointed | 14 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Extremely upset or disappointed | 11 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 8, Extremely upset or disappointed | 17 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Opinions About Conditional Economic Incentive (CEI) Withdrawal | Week 0, Undecided | 14 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1
Summarized the percentage of participants with plasma HIV-1 RNA level less than 200 copies/mL by study visit
Time frame: Measured from Step 1 entry through Step 1, Week 20 visit
Population: Step 1 used Intention-to-Treat (ITT) population which was defined as all eligible participants who registered to Step 1, regardless of status on treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Baseline | 34 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Week 4 | 74 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Week 8 | 68 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Week 12 | 74 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Week 16 | 67 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 1 | Week 20 | 74 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2
Summarized the percentage of participants with plasma HIV-1 RNA level less than 200 copies/mL by study visit, and randomized treatment.
Time frame: Measured from Step 2 entry through Step 2, Week 48 visit
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Baseline | 84 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 8 | 95 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 16 | 97 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 24 | 98 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 36 | 98 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 48 | 95 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 36 | 81 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Baseline | 93 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 24 | 77 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 8 | 81 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 48 | 86 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 200 Copies/mL at Scheduled Study Visits on Steps 2 | Week 16 | 80 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1
Summarized the percentage of participants with plasma HIV-1 RNA level less than 50 copies/mL by study visit
Time frame: Measured from Step 1 entry through Step 1, Week 20 visit
Population: Step 1 used Intention-to-Treat (ITT) population which was defined as all eligible participants who registered to Step 1, regardless of status on treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Baseline | 21 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Week 4 | 57 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Week 8 | 47 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Week 12 | 55 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Week 16 | 56 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 1 | Week 20 | 63 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2
Summarized the percentage of participants with plasma HIV-1 RNA level less than 50 copies/mL by study visit, and randomized treatment.
Time frame: Measured from Step 2 entry through Step 2, Week 48 visit
Population: Intention-to-Treat (ITT) Population was defined as all eligible participants who were randomized to the treatment arms, regardless of status on randomized treatment. Participants were assessed according to their randomized treatment, regardless of the treatment they received
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Baseline | 72 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 8 | 88 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 16 | 84 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 24 | 93 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 36 | 90 percentage of participants |
| Step 2 Arm A: LA ART | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 48 | 87 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 36 | 69 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Baseline | 81 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 24 | 69 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 8 | 68 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 48 | 78 percentage of participants |
| Step 2 Arm B: SOC | Percentage of Participants With Plasma HIV-1 RNA Level Less Than 50 Copies/mL at Scheduled Study Visits on Steps 2 | Week 16 | 67 percentage of participants |