HIV-1-infection
Conditions
Brief summary
The goal of this clinical study is to learn how safe it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.
Interventions
DRUGB/F/TAF
Tablets administered orally without regard to food
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * People with human immunodeficiency virus type 1 (HIV-1) (PWH) or provider decision to switch off cabotegravir + rilpivirine (CAB+RPV) intramuscular (IM) injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). * Currently virologically suppressed (HIV-1 ribonucleic acid (RNA) \< 50 copies/mL) on CAB+RPV IM injections every 2 months. * Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections. * Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV. * Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit. * No documented or suspected resistance to bictegravir, emtricitabine, or tenofovir. Key
Exclusion criteria
* History of B/F/TAF intolerance. * History of previous integrase strand-transfer inhibitor (INSTI) virologic failure including CAB+RPV. * Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug. * Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies) * Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1 Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint) | Week 12 | Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale. The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death |
| Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint) | Week 12 | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days. The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose) | Day 1 (Predose) | — |
| Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 | Week 4 (at trough and 2 hours postdose) | — |
| Plasma Concentration of BIC, CAB, and RPV at Week 12 | Week 12 (at trough and 2 hours postdose) | — |
| Plasma Concentration of BIC, CAB, and RPV at Week 24 | Week 24 (at trough and 2 hours postdose) | — |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach | Week 12 | This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis. |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach | Week 24 | This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis. |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach | Week 12 | This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA \>= 50 copies/mL (failure) in the analysis. |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach | Week 24 | This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA \>= 50 copies/mL (failure) in the analysis. |
| Percentage of Participants With Discontinuation of B/F/TAF by Week 12 | Up to 12 Weeks | — |
| Percentage of Participants With Discontinuation of B/F/TAF by Week 24 | Up to 24 Weeks | — |
| Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24 | Week 24 | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days. The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening. |
| HIV Treatment Satisfaction (HIVTSQc) Score at Week 4 | Week 4 | The HIVTSQc was a 1-12 items questionnaire. Each item was scored -3 to 3. The total score ranged from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. |
Countries
Canada, France, United States
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States, France, and Canada.
Pre-assignment details
36 participants were screened.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 14.7 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Not Collected | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 20 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 6 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Not Collected | 4 Participants |
| Race/Ethnicity, Customized Race Other or More Than One Race | 2 Participants |
| Race/Ethnicity, Customized Race White | 18 Participants |
| Region of Enrollment Canada | 2 Participants |
| Region of Enrollment France | 4 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 33 |
| other Total, other adverse events | 10 / 33 |
| serious Total, serious adverse events | 2 / 33 |
Outcome results
None listed