INSTI's For The Management of HIV-associated TB (NCT04734652) | Clinical Trial Compass
CompletedPhase 2
INSTI's For The Management of HIV-associated TB
South Africa122 participantsStarted 2022-02-18
Plain-language summary
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
Who can participate
Age range18 Years – 105 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Pregnancy or breastfeeding (or planned pregnancy within 12 months of study entry)
* 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
* Part…
What they're measuring
1
Number of Participants With Viral Suppression at Week 24
Timeframe: Week 24
Trial details
NCT IDNCT04734652
SponsorCentre for the AIDS Programme of Research in South Africa