Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo pill shows promise for HIV patients fighting TB

NCT ID NCT04734652

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Feb 2022

Finished

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

Anyone

Healthy volunteers

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

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV-1-infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.