Bictegravir Efficacy With 1st INSTI Generation Failure History
NCT07930923, Not yet recruiting, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Bictegravir Efficacy With 1st INSTI Generation Failure History | ClinicalTrials.gov |
| NCT number | NCT07930923 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 635 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | ClinicalTrials.gov |
| Conditions | HIV | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants with HIV-1 RNA <50 copies/mL in Patient living with HIV(PLWH) with virologic failure (VF) and virologically unsuppressed (VU). Analyzed to the FDA snapshot | Week 48 | Group#1: PLWH with a prior VF on RAL- or EVG-based regimens and virologically suppressed (VS) (defined as HIV plasma RNA \<50 copies/mL) at the time of switching to B/F/TAF Group#2: PLWH with a prior VF on RAL- or EVG-based regimens and virologically unsuppressed (VU) (defined as a HIV plasma RNA ≥50 copies/mL) at the time of switching to B/F/TAF. | ClinicalTrials.gov |
| Secondary | Proportion of participants with HIV-1 RNA <50 copies/mL analyzed to the FDA snapshot in Patient living with HIV with virologic failure (VF) (group 1)and virologically unsuppressed (VU) (group 2). Analyzed to the FDA snapshot | week 96 | ClinicalTrials.gov | |
| Secondary | Time to B/F/TAF discontinuation and reason for discontinuation in group 1 and 2 | week 96 | Time (in weeks) from B/F/TAF initiation to treatment discontinuation, evaluated through 96 weeks of follow-up, along with the distribution of reasons for discontinuation. | ClinicalTrials.gov |
| Secondary | Number of participants initiating subsequent regimens after B/F/TAF discontinuation | week 96 | Count of participants who initiated a subsequent antiretroviral regimen following B/F/TAF discontinuation, categorized by regimen type, evaluated through week 96. | ClinicalTrials.gov |
| Secondary | Number of participants with B/F/TAF emerging resistance at confirmed virologic failure | week 48 | Count of participants experiencing confirmed virologic failure who developed emerging resistance-associated mutations to B/F/TAF through week 48. | ClinicalTrials.gov |
| Secondary | Changes from baseline in CD4 and CD8 cell | week 48 | ClinicalTrials.gov | |
| Secondary | Changes from baseline in CD4/CD8 ratio, | week 48 | ClinicalTrials.gov | |
| Secondary | Changes from baseline in Body Mass index | week 48 | ClinicalTrials.gov | |
| Secondary | Changes from baseline in body weight | week 48 | ClinicalTrials.gov | |
| Secondary | Number of participants with documented InSTI resistance-associated mutations at baseline | Baseline | Count of participants in groups 1 and 2 with documented InSTI resistance-associated mutations (RAMs) at baseline. | ClinicalTrials.gov |
| Secondary | Number of participants with documented NRTI and their impact on B/F/TAF virologic outcomes. | Baseline | ClinicalTrials.gov | |
| Secondary | Number of participants with documented NNRTI and their impact on B/F/TAF virologic outcomes. | Baseline | ClinicalTrials.gov | |
| Secondary | Number of participants with documented PI and their impact on B/F/TAF virologic outcomes. | Baseline | ClinicalTrials.gov | |
| Secondary | number of participant with Resistance to impact on B/F/TAF virologic outcomes in group 1 and 2 | Baseline | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.