HIV Infections
Conditions
Keywords
Pre-Exposure Prophylaxis, PrEP
Brief summary
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). This study will enroll HIV-uninfected MSM and TGW at risk for acquiring HIV infection. Participants will be followed for a total of 4 years. This study will take place in three steps. Participants will be randomly assigned to one of two arms: Arm A: Step 1: Participants will receive daily oral CAB tablets and daily oral TDF/FTC placebo tablets for 5 weeks. Step 2: Participants will receive an intramuscular (IM) injection of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo tablets to Week 153. Arm B: Step 1: Participants will receive daily oral TDF/FTC tablets and daily oral CAB placebo tablets for 5 weeks. Step 2: Participants will receive daily oral TDF/FTC tablets and an IM injection of placebo at two time points 4 weeks apart and every 8 weeks thereafter to Week 153. In Step 3, all participants (Arms A and B) will receive daily oral TDF/FTC tablets starting at Week 153 (last day of Step 2)/Day 0 (first day of Step 3) and continue for 48 weeks. Participants will attend up to 47 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, an electrocardiogram (ECG), and rectal swab collection. Some participants may have a bone mineral density-energy x-ray absorptimetry (DXA) scan at select visits. All participants will be transitioned to locally available HIV prevention services, including services for PrEP, if available, at the end of their participation in the study. HPTN 083-01 is a sub-study of HPTN 083. The purpose of this study is to evaluate the safety, tolerability, and acceptability of CAB LA for the prevention of HIV among adolescent males. Participants will receive oral CAB for 5 weeks, followed by 29 weeks on CAB LA, then quarterly visits for 48 weeks after final injection. All participants who have received at least one injection will be followed for 48 weeks after their last injection. Total study duration per participant will be approximately 21 months. HPTN 083-02 is a qualitative sub-study of participants enrolled in HPTN 083. The purpose of this study is to explore potential barriers, facilitators, and potentially modifiable issues related to adherence to clinic visits in the context of injectable PrEP; to learn about preferences and decision making regarding the use of oral versus injectable PrEP, or other biomedical prevention products; and to gather explanatory qualitative data regarding participants' experiences in HPTN 083 to better interpret study results and guide next prevention strategies. Participants in this sub-study will complete one individual semi-structured qualitative interview.
Interventions
DRUGCabotegravir Oral Tablet
30 mg tablet
DRUGTDF/FTC tablets
300 mg/200 mg fixed-dose combination tablets
DRUGPlacebo for TDF/FTC tablets
DRUGPlacebo for cabotegravir oral tablet
DRUGCAB LA
Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
ViiV Healthcare
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* MSM and TGW, 18 years or older at the time of screening (male at birth) * Willing to provide informed consent for the study * At high risk for sexually acquiring HIV infection based on self-report of at least one of the following: * Any condomless receptive anal intercourse in the 6 months prior to enrollment (condomless anal intercourse within a monogamous HIV seronegative concordant relationship does not meet this criterion) * More than five partners in the 6 months prior to enrollment (regardless of condom use and HIV serostatus, as reported by the enrollee) * Any stimulant drug use in the 6 months prior to enrollment * Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to enrollment * SexPro score of less than or equal to 16 (U.S. sites only) * In general good health, as evidenced by the following laboratory values, which must be from specimens obtained within 45 days prior to study enrollment: * Non-reactive / negative HIV test results. More information on this criterion can be found in the protocol. * Hemoglobin greater than 11 g/dL, * Absolute neutrophil count greater than 750 cells/mm\^3 * Platelet count greater than or equal to 100,000/mm\^3 * Calculated creatinine clearance greater than or equal to 60 mL/minute using the Cockcroft-Gault equation (use sex at birth for calculation) * Although not protocol exclusionary, sites should carefully consider the advisability of enrolling participants with calculated creatinine clearance between 60-70 mL/min, as limited changes in creatinine clearance during study conduct will lead to protocol-mandated product holds and may alter the risk-benefit considerations of study participation * Alanine aminotransferase (ALT) less than 2 times the upper limit of normal (ULN) * Total bilirubin less than or equal to 2.5 times ULN * Hepatitis B virus (HBV) surface antigen (HBsAg) negative * Hepatitis C virus (HCV) Ab negative * No Grade 3 or higher laboratory abnormalities on any laboratory tests obtained at screening, including tests obtained as part of a panel of tests ordered to obtain the protocol-required laboratory test results. * No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records) * Willing to undergo all required study procedures
Exclusion criteria
* One or more reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed * Active or recent use of any illicit intravenous drugs ("recent" defined as in the 90 days prior to enrollment) * Co-enrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation. Exceptions may be made if appropriate after consultation with the CMC.) * Past or current participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm). Note: Past participation in a monoclonal antibody study is not exclusionary, effective as of Version 1.0 of HPTN 083. * Clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease * Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, per the discretion of the Investigator of Record. Mild skin conditions may not be exclusionary at the discretion of the Investigator of Record (IoR) or designee in consultation with the CMC * Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the IoR or designee, in consultation with the CMC, may interfere with interpretation of injection site reactions * Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy) * Coagulopathy (primary or iatrogenic) which would contraindicate IM injection (concomitant anticoagulant or anti-platelet therapy use should be discussed with the CMC) * Active or planned use of prohibited medications as described in the Investigator's Brochure or listed in the Study Specific Procedures (SSP) Manual (provided by self-report, or obtained from medical history or medical records). In particular, future use of TDF/FTC at any point during the study. * Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid) * Surgically-placed or injected buttock implants or fillers, per self-report. Contact the CMC for guidance regarding questions about individual cases. * Alcohol or substance use that, in the opinion of the study investigator, would jeopardize the safety of the participant on study (e.g., provided by self-report, or found upon medical history and examination or in available medical records). * History of seizure disorder, per self-report * QTc interval (B or F) greater than 500 msec
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. | All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC). |
| Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks). | The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Documented Incident HIV Infections in Step 2 | HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest. | Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population |
| Changes From Baseline in Creatinine and Creatinine Clearance Levels | Reported week 57 (injection visit #8) and week 105 (injection visit #14) | Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit. |
| Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs) | Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks) | Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus. |
| Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center | Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection. |
| Changes in Weight From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks). | Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit. |
| Changes in Systolic Blood Pressure From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole. |
| Changes in Diastolic Blood Pressure From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole. |
| Changes in Pulse Rate From Baseline | Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks). | Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit. |
| Changes in Fasting Glucose Levels From Baseline | Assessed at weeks 57 and 105. | Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations. |
| Changes in Fasting Lipid Profile From Baseline | Assessed at weeks 57 and 105. | Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations. |
| Summary of Overall Satisfaction With Study Product | Assessed at Week 17, 41 | Summary of overall satisfaction with study product at Week 17 and Week 41. 0 represents None of the time and 6 represents All of the times for the questions 'How often is it inconvenient or difficult to receive oral study medication as recommended?' and 'How often do you find it inconvenient or difficult to receive your injection as recommended?', 0 represents None at all and 6 represent A very great deal for the questions 'How much pain or discomfort have you experienced with your oral study medication (tablets)?' and 'How much pain or discomfort have you experienced with your injection?'. |
| Summary of Preference Based on Satisfaction With Study Product | Assessed at week 17, 41 | Summary of preference based on satisfaction with study product at Week 17 and Week 41 |
| Change From Baseline of Mean Z-scores of Bone Mineral Density | Measured at enrollment, week 57 and week 105 | Change from baseline of mean standard scores (Z-scores) to week 57 and week 105 in the bone mineral density (BMD) at femoral neck, lumbar spine, and total hip region were summarized using DEXA subset. BMD z-scores from Hologic instrument scans were standardized by race, age, and gender using the Hologic DXA Reference Data. Male reference values were used for men who have sex with men and female reference values for transgender women. A z-score of 0 represents the mean of the analysis population standardized by race, age, and gender. Higher z-scores in BMD indicate a better outcomes. A z-score of -2.0 or lower is generally considered below the expected range, potentially indicating secondary osteoporosis requiring further medical evaluation. |
Countries
Argentina, Brazil, Peru, South Africa, Thailand, United States, Vietnam
Contacts
STUDY_CHAIRRaphael J. Landovitz, MD, MSc
University of California, Los Angeles
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cabotegravir In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
Cabotegravir tablets: 30 mg tablets
TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets
TDF/FTC placebo tablets
CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter | 2,283 |
| TDF/FTC In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets
CAB placebo tablets
Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter | 2,287 |
| Total | 4,570 |
Baseline characteristics
| Characteristic | Cabotegravir | Total | TDF/FTC |
|---|---|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 8.17 | 28.1 years STANDARD_DEVIATION 8.15 | 28.2 years STANDARD_DEVIATION 8.14 |
| Age, Customized 18-24 years | 931 Participants | 1846 Participants | 915 Participants |
| Age, Customized 25-34 years | 940 Participants | 1871 Participants | 931 Participants |
| Age, Customized <30 years | 1572 Participants | 3082 Participants | 1510 Participants |
| Age, Customized >=30 years | 711 Participants | 1488 Participants | 777 Participants |
| Age, Customized 35-44 years | 285 Participants | 598 Participants | 313 Participants |
| Age, Customized 45-54 years | 103 Participants | 212 Participants | 109 Participants |
| Age, Customized 55-60 years | 19 Participants | 36 Participants | 17 Participants |
| Age, Customized 61+ years | 5 Participants | 7 Participants | 2 Participants |
| Education College/University or Higher, complete | 868 Participants | 1684 Participants | 816 Participants |
| Education College/University or Higher, not complete | 708 Participants | 1420 Participants | 712 Participants |
| Education No Schooling | 2 Participants | 8 Participants | 6 Participants |
| Education Primary School, complete | 16 Participants | 41 Participants | 25 Participants |
| Education Primary School, not complete | 12 Participants | 29 Participants | 17 Participants |
| Education Secondary School, complete | 371 Participants | 781 Participants | 410 Participants |
| Education Secondary School, not complete | 119 Participants | 232 Participants | 113 Participants |
| Education Technical Training, complete | 113 Participants | 222 Participants | 109 Participants |
| Education Technical Training, not complete | 74 Participants | 153 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1043 Participants | 2110 Participants | 1067 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1240 Participants | 2459 Participants | 1219 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Marital Status Have Primary or Main Partner, not Living Together | 171 Participants | 336 Participants | 165 Participants |
| Marital Status Living with Primary or Main Partner | 138 Participants | 292 Participants | 154 Participants |
| Marital Status Married/Civil Union/Legal Partnership | 79 Participants | 177 Participants | 98 Participants |
| Marital Status Other | 6 Participants | 11 Participants | 5 Participants |
| Marital Status Single/Divorced/Widowed | 1889 Participants | 3754 Participants | 1865 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 616 Participants | 1216 Participants | 600 Participants |
| Race (NIH/OMB) Asian | 417 Participants | 823 Participants | 406 Participants |
| Race (NIH/OMB) Black or African American | 565 Participants | 1134 Participants | 569 Participants |
| Race (NIH/OMB) More than one race | 49 Participants | 103 Participants | 54 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 20 Participants | 7 Participants |
| Race (NIH/OMB) White | 618 Participants | 1267 Participants | 649 Participants |
| Region of Enrollment Africa | 78 participants | 152 participants | 74 participants |
| Region of Enrollment Argentina | 169 participants | 337 participants | 168 participants |
| Region of Enrollment Brazil | 395 participants | 796 participants | 401 participants |
| Region of Enrollment Peru | 416 participants | 832 participants | 416 participants |
| Region of Enrollment Thailand | 275 participants | 553 participants | 278 participants |
| Region of Enrollment United States | 850 participants | 1701 participants | 851 participants |
| Region of Enrollment Vietnam | 100 participants | 199 participants | 99 participants |
| Sex/Gender, Customized Men who have sex with men | 2014 Participants | 3996 Participants | 1982 Participants |
| Sex/Gender, Customized Prefer not to answer | 3 Participants | 4 Participants | 1 Participants |
| Sex/Gender, Customized Transgender women | 266 Participants | 570 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 2,281 | 7 / 2,285 |
| other Total, other adverse events | 2,103 / 2,281 | 2,114 / 2,285 |
| serious Total, serious adverse events | 117 / 2,281 | 109 / 2,285 |
Outcome results
Primary
Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events
The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.
Time frame: Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).
Population: Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabotegravir | Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | 2106 Participants |
| TDF/FTC | Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events | 2116 Participants |
Primary
Number of Participants With Documented Incident HIV Infections During Steps 1 and 2
All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).
Time frame: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
Population: mITT Population (Steps 1 and 2): Participants who were inappropriately enrolled are excluded. Participants who were found by the EAC to be HIV infected at enrollment are excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabotegravir | Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | 13 Participants |
| TDF/FTC | Number of Participants With Documented Incident HIV Infections During Steps 1 and 2 | 39 Participants |
p-value: 0.000595% CI: [0.18, 0.62]Regression, Cox
p-value: 0.000595% CI: [0.18, 0.61]Regression, Cox
Secondary
Changes From Baseline in Creatinine and Creatinine Clearance Levels
Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.
Time frame: Reported week 57 (injection visit #8) and week 105 (injection visit #14)
Population: All subjects who received at least one dose of study product, and for whom have results for creatine and creatinine clearance at enrollment AND for at least one of the following two time points: Week 57 and Week 105.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes From Baseline in Creatinine and Creatinine Clearance Levels | Week 57 (Injection #8) | 0.90 umol/L |
| Cabotegravir | Changes From Baseline in Creatinine and Creatinine Clearance Levels | Week 105 (Injection #14) | 0.90 umol/L |
| TDF/FTC | Changes From Baseline in Creatinine and Creatinine Clearance Levels | Week 57 (Injection #8) | 1.70 umol/L |
| TDF/FTC | Changes From Baseline in Creatinine and Creatinine Clearance Levels | Week 105 (Injection #14) | 2.30 umol/L |
Secondary
Changes in Diastolic Blood Pressure From Baseline
Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.
Time frame: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).
Population: Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 121 (Injection #16) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 5 (Injection #1) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 49 (Injection #7) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 57 (Injection #8) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 65 (Injection #9) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 73 (Injection #10) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 81 (Injection #11) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 89 (Injection #12) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 97 (Injection #13) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 105 (Injection #14) | 0.5 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 113 (Injection #15) | 1.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 9 (Injection #2) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 17 (Injection #3) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 25 (Injection #4) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 33 (Injection #5) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 41 (Injection #6) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 129 (Injection #17) | 1.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 137 (Injection #18) | 0.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 145 (Injection #19) | 1.0 mmHg |
| Cabotegravir | Changes in Diastolic Blood Pressure From Baseline | Week 153 (Injection #20) | 2.5 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 137 (Injection #18) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 121 (Injection #16) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 113 (Injection #15) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 41 (Injection #6) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 49 (Injection #7) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 9 (Injection #2) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 57 (Injection #8) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 5 (Injection #1) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 153 (Injection #20) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 65 (Injection #9) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 17 (Injection #3) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 73 (Injection #10) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 129 (Injection #17) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 81 (Injection #11) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 25 (Injection #4) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 89 (Injection #12) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 145 (Injection #19) | -2.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 97 (Injection #13) | -1.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 33 (Injection #5) | 0.0 mmHg |
| TDF/FTC | Changes in Diastolic Blood Pressure From Baseline | Week 105 (Injection #14) | 0.0 mmHg |
Secondary
Changes in Fasting Glucose Levels From Baseline
Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.
Time frame: Assessed at weeks 57 and 105.
Population: Participants who were inappropriately enrolled are excluded. Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes in Fasting Glucose Levels From Baseline | Week 105 | 1.0 mg/dL |
| Cabotegravir | Changes in Fasting Glucose Levels From Baseline | Week 57 | 1.0 mg/dL |
| TDF/FTC | Changes in Fasting Glucose Levels From Baseline | Week 57 | 0.0 mg/dL |
| TDF/FTC | Changes in Fasting Glucose Levels From Baseline | Week 105 | 1.8 mg/dL |
Secondary
Changes in Fasting Lipid Profile From Baseline
Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.
Time frame: Assessed at weeks 57 and 105.
Population: Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | Total Cholesterol Week 57 | 1.0 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | Total Cholesterol Week 105 | 4.0 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | HDL Week 105 | -0.9 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | Trigylcerides Week 57 | 2.7 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | Trigylcerides Week 105 | 7.5 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | LDL Week 57 | 1.0 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | LDL Week 105 | 3.0 mg/dL |
| Cabotegravir | Changes in Fasting Lipid Profile From Baseline | HDL Week57 | -0.2 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | HDL Week 105 | -3.0 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | Total Cholesterol Week 57 | -10.0 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | Trigylcerides Week 105 | 2.0 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | Total Cholesterol Week 105 | -7.5 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | HDL Week57 | -3.0 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | LDL Week 105 | -4.0 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | LDL Week 57 | -6.0 mg/dL |
| TDF/FTC | Changes in Fasting Lipid Profile From Baseline | Trigylcerides Week 57 | 0.0 mg/dL |
Secondary
Changes in Pulse Rate From Baseline
Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.
Time frame: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).
Population: Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 5 (Injection #1) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 9 (Injection #2) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 121 (Injection #16) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 17 (Injection #3) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 25 (Injection #4) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 33 (Injection #5) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 41 (Injection #6) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 49 (Injection #7) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 57 (Injection #8) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 65 (Injection #9) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 73 (Injection #10) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 81 (Injection #11) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 89 (Injection #12) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 97 (Injection #13) | 3.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 129 (Injection #17) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 105 (Injection #14) | 2.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 113 (Injection #15) | 4.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 137 (Injection #18) | 5.5 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 145 (Injection #19) | 4.0 beats/min |
| Cabotegravir | Changes in Pulse Rate From Baseline | Week 153 (Injection #20) | 4.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 105 (Injection #14) | 1.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 5 (Injection #1) | 1.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 73 (Injection #10) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 153 (Injection #20) | 3.5 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 121 (Injection #16) | 3.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 9 (Injection #2) | 1.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 81 (Injection #11) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 17 (Injection #3) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 113 (Injection #15) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 25 (Injection #4) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 89 (Injection #12) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 33 (Injection #5) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 129 (Injection #17) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 41 (Injection #6) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 97 (Injection #13) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 49 (Injection #7) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 145 (Injection #19) | 2.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 57 (Injection #8) | 0.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 137 (Injection #18) | 3.0 beats/min |
| TDF/FTC | Changes in Pulse Rate From Baseline | Week 65 (Injection #9) | 2.0 beats/min |
Secondary
Changes in Systolic Blood Pressure From Baseline
Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.
Time frame: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).
Population: Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 73 (Injection #10) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 41 (Injection #6) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 81 (Injection #11) | 0.5 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 145 (Injection #19) | 1.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 9 (Injection #2) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 153 (Injection #20) | 2.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 49 (Injection #7) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 89 (Injection #12) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 25 (Injection #4) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 113 (Injection #15) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 97 (Injection #13) | 1.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 5 (Injection #1) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 105 (Injection #14) | 1.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 57 (Injection #8) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 121 (Injection #16) | 1.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 33 (Injection #5) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 129 (Injection #17) | 2.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 65 (Injection #9) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 137 (Injection #18) | 0.0 mmHg |
| Cabotegravir | Changes in Systolic Blood Pressure From Baseline | Week 17 (Injection #3) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 137 (Injection #18) | 2.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 5 (Injection #1) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 9 (Injection #2) | -1.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 17 (Injection #3) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 25 (Injection #4) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 33 (Injection #5) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 41 (Injection #6) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 81 (Injection #11) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 49 (Injection #7) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 57 (Injection #8) | -1.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 65 (Injection #9) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 73 (Injection #10) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 145 (Injection #19) | 3.5 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 153 (Injection #20) | 2.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 89 (Injection #12) | -1.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 97 (Injection #13) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 113 (Injection #15) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 121 (Injection #16) | 0.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 129 (Injection #17) | 2.0 mmHg |
| TDF/FTC | Changes in Systolic Blood Pressure From Baseline | Week 105 (Injection #14) | 0.0 mmHg |
Secondary
Changes in Weight From Baseline
Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.
Time frame: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).
Population: Enrolled participants with available data at each visit
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cabotegravir | Changes in Weight From Baseline | Week 5 (Injection #1) | 0.4 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 81 (Injection #11) | 2.0 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 41 (Injection #6) | 1.2 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 89 (Injection #12) | 2.2 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 65 (Injection #9) | 1.7 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 97 (Injection #13) | 2.1 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 33 (Injection #5) | 1.0 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week #105 (Injection #14) | 2.1 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week #73 (Injection #10) | 1.8 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 113 (Injection #15) | 2.6 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 49 (Injection #7) | 1.5 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 121 (Injection #16) | 2.8 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 9 (Injection #2) | 0.5 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 25 (Injection #4) | 0.9 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 137 (Injection #18) | 2.7 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 17 (Injection #3) | 0.7 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 145 (Injection #19) | 2.7 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 57 (Injection #8) | 1.2 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 153 (Injection #20) | 2.9 Kg |
| Cabotegravir | Changes in Weight From Baseline | Week 129 (Injection #17) | 2.9 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 153 (Injection #20) | 0.7 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 25 (Injection #4) | -0.2 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 33 (Injection #5) | 0.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 41 (Injection #6) | 0.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 49 (Injection #7) | 0.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 57 (Injection #8) | 0.2 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 65 (Injection #9) | 0.5 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 5 (Injection #1) | 0.1 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 9 (Injection #2) | 0.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 17 (Injection #3) | 0.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week #73 (Injection #10) | 0.5 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 81 (Injection #11) | 0.5 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 89 (Injection #12) | 0.5 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 97 (Injection #13) | 1.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week #105 (Injection #14) | 0.9 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 113 (Injection #15) | 1.4 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 121 (Injection #16) | 1.0 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 129 (Injection #17) | 1.3 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 137 (Injection #18) | 1.2 Kg |
| TDF/FTC | Changes in Weight From Baseline | Week 145 (Injection #19) | 1.9 Kg |
Secondary
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters
Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.
Time frame: Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center
Population: All participants in the mITT population who acquired HIV, including those who were found to have acquired HIV prior to randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabotegravir | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | PI resistance | 0 Participants |
| Cabotegravir | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | NRTI resistance | 1 Participants |
| Cabotegravir | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | NNRTI resistance | 3 Participants |
| Cabotegravir | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | INSTI resistance | 6 Participants |
| Cabotegravir | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | Any resistance | 8 Participants |
| TDF/FTC | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | INSTI resistance | 0 Participants |
| TDF/FTC | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | Any resistance | 13 Participants |
| TDF/FTC | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | PI resistance | 0 Participants |
| TDF/FTC | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | NNRTI resistance | 10 Participants |
| TDF/FTC | Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters | NRTI resistance | 6 Participants |
Secondary
Number of Participants With Documented Incident HIV Infections in Step 2
Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population
Time frame: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
Population: Injection step 2 efficacy: The subgroup of the mITT population who received at least one injection and had at least one HIV result assessed after the first injection visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabotegravir | Number of Participants With Documented Incident HIV Infections in Step 2 | 8 Participants |
| TDF/FTC | Number of Participants With Documented Incident HIV Infections in Step 2 | 37 Participants |
Comparison: The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.p-value: <0.00195% CI: [0.1, 0.45]Regression, Cox
Secondary
Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)
Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.
Time frame: Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)
Population: Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabotegravir | Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs) | 73 Participants |
| TDF/FTC | Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs) | 96 Participants |