Phase 2
Completed N=122
INSTI's For The Management of HIV-associated TB
HIV · Tuberculosis, Pulmonary
Source: ClinicalTrials.gov NCT04734652 ↗
Enrolled (actual)
122
Serious AEs
11.5%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Viral Suppression at Week 24 — 75; 40; 0; 0 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Viral Suppression at Week 24 |
75; 40; 0; 0 | — |
| SECONDARY Viral Suppression Rates (HIV-1 RNA <50 Copies/mL) at Weeks 12, 24 and 48 in the DTG Arm and at 12 and 48 Weeks in the BIC Arm |
— | — |
| SECONDARY BIC Drug Concentrations ("Area Under the Plasma Concentration Versus Time Curve (AUC)" |
— | — |
| SECONDARY BIC Drug Concentrations [Peak Plasma Concentration (Cmax)] |
— | — |
| SECONDARY BIC Drug Concentrations [Trough/Minimum Plasma Concentration Ctrough) |
— | — |
| SECONDARY The Incidence of TB Associated IRIS |
— | — |
| SECONDARY The Tolerability of Treatment in Each Arm |
— | — |
| SECONDARY Frequency of ART Drug Resistance Mutations in Participants With Detectable Viral Load at Weeks 24 and 48 |
— | — |
Eligibility Criteria
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) 500mg, 12hourly)
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT04734652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.