Status:
COMPLETED
INSTI's For The Management of HIV-associated TB
Lead Sponsor:
Centre for the AIDS Programme of Research in South Africa
Collaborating Sponsors:
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV/AIDS
Tuberculosis, Pulmonary
Eligibility:
All Genders
18-105 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
Primary objective: To characterize viral suppression rates (proportion of patients with suppressed viral load) at week 24 in the BIC arm Secondary objectives: To characterize viral suppression rates...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Patients on metformin (\> 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)
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04734652
Start Date
February 18 2022
End Date
August 31 2024
Last Update
October 3 2025
Active Locations (1)
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1
CAPRISA Springfield Clinical Research Site
Durban, KwaZulu-Natal, South Africa, 4001