NCT04734652CompletedPhase 2
INSTI's For The Management of HIV-associated TB
A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug Susceptible-TB on a Rifampicin-based Regimen
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected, ART-naïve patients with TB co-infection receiving a rifampicin-based tuberculosis (TB) treatment regimen. This study will assess the activity of Bictegravir and dolutegravir-containing ART regimens in patients with drug-susceptible TB through 48 weeks
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 122 (actual)
- First submitted
- 11 Jan 2021
- Start date
- 18 Feb 2022
- Primary completion date
- 19 Jan 2024
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04734652
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 122
- From 18 Feb 2022 to the primary completion date, 19 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of antiretroviral drugs for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) \< 3 months at the time of enrolment
- Hepatitis B surface antigen positive OR Hepatitis B virus (HBV) infection OR active systemic infections (other than HIV-1 infection) requiring systemic antibiotic or antifungal therapy current or within 30 days prior to baseline that could, in the opinion of the investigator, interfere with study procedures or assessment of study outcomes
Other illness
- Patients with an uncontrolled psychiatric co-morbidity. Patients who, in the investigator's judgment, pose a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk
- Other condition or circumstance deemed by clinician/investigators to be detrimental to patient safety or study conduct
Lab values
- Participants with a CD4+ cell count of \< 50 cells/ μl
- Any verified Grade 4 laboratory abnormality, with the exception of, Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result
Other
- Pregnancy or breastfeeding (or planned pregnancy within 12 months of study entry)
- Patients on metformin (\> 500mg, 12hourly)
- Unwilling to be part of the main pharmacokinetic (PK) study and have PK blood draws done (NB there is a semi-intensive PK substudy which is optional)
Who the study is looking for
- Adults ≥ 18 years of age with Karnofsky score ≥ 70
- Confirmed rifampicin-susceptible tuberculosis and/or
- On first-line rifampicin-based tuberculosis treatment (not \> 8 weeks at the time of enrolment)
- Documented HIV-1 infection, ART-naïve OR ART non-naïve (patients to have no exposure to ART medication at least ≥ 3 months at the time of enrollment)
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2
- Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)
- Total bilirubin ≤2.5 times ULN
- Creatinine ≤2 times ULN
- Hemoglobin ≥ 7.0 g/dL (6.5 g/dL for females)
- Platelet count ≥ 50,000/mm3
- Absolute Neutrophil Count (ANC) ≥650/mm3
- Able and willing to provide written informed consent
- Female patients agree to use both a barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment
Age in the registry: 18 years to 105 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CAPRISA Springfield Clinical Research Site Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.