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New combo pill shows promise for HIV patients fighting TB
NCT ID NCT04734652
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new HIV medication (Biktarvy) taken twice daily in 122 adults who also have drug-sensitive tuberculosis (TB) and are on standard TB treatment. The goal was to see if the new pill can control HIV just as well as the current standard treatment. The study measured how many people had undetectable HIV levels after 24 and 48 weeks, while also monitoring safety and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
122 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Aug 2024
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 105 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CAPRISA Springfield Clinical Research Site
Durban, KwaZulu-Natal, 4001, South Africa
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Other studies related to the condition(s) this trial covers.
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