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

Gå till den engelska sidan

Double-Dose HIV drug shows promise for Co-Infected patients

NCT ID NCT05630872

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This study tested whether taking a double dose of the HIV drug dolutegravir (50 mg twice daily) along with the TB drug rifapentine can keep HIV under control in people with both HIV and tuberculosis. Thirty adults participated. The goal was to see if the higher dose is safe and effective enough to prevent the HIV virus from rebounding.

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

30 people

The number who actually took part.

Started

Feb 2024

Finished

Nov 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Weight ≥40 kg. * Ability and willingness of participant or legal guardian/representative to provide informed consent. * Documentation of HIV-1 status. * CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry at any network-approved non-US laboratory that is IQA certified. * ART-naïve or not on ART for 12 consecutive weeks prior to TB diagnosis. * Willingness and eligibility to start DTG-based ART at 6 weeks, with a window of ±1 week, after starting TB treatment, with no intention to change ART for the duration of the study. * Documentation of pulmonary TB. * Willingness to start 2HPZM/2HPM therapy for DS-TB. * The following laboratory values obtained within 30 days prior to study entry: * Absolute neutrophil count (ANC) \>750 cells/mm3 * Hemoglobin ≥7.4 g/dL * Platelet count ≥50,000/mm3 * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \<2.5 X the upper limit of normal (ULN) * Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \<2.5 x ULN * Total bilirubin ≤1.5 x ULN * Creatinine \<1.3 x ULN * For participants who can become pregnant, negative serum or urine pregnancy test at screening within 30 days prior to entry and within 48 hours prior to entry. * Participants who can become pregnant must agree not to participate in the conception process and if participating in sexual activity that could lead to pregnancy, must agree to use one reliable nonhormonal method of contraception. * Documentation of Karnofsky performance score ≥50 within 30 days prior to entry. Exclusion Criteria: * Breastfeeding, pregnant, or plans to become pregnant. * Known allergy/sensitivity or any hypersensitivity to components of the study drugs, or their formulations. * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Requirement for ongoing use of drugs that are known to have significant drug-drug interactions with DTG or RPT. * Known history of acute intermittent porphyria. * Previous treatment for active TB disease within 6 months preceding initiation of study drugs. * More than 5 days of treatment directed against active TB for the current TB episode preceding study entry. * At the time of study entry, documentation of an M. tuberculosis isolate from the current or previous treatment episode known to be resistant to RIF or INH. * Known history of prolonged QT syndrome. * Known cirrhosis, a history of decompensated liver disease (ascites, hepatic encephalopathy, or esophageal varices). * Documentation of severe opportunistic infections, in the opinion of the site investigator, within 3 months of study entry. * Documentation of severe extra-pulmonary TB (e.g., meningitis, osteomyelitis, disseminated TB) at the time of screening. * Acute gout at the time of screening.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV 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

  • Durban International CRS (Site # 11201)

    Wentworth, Durban, 4052, South Africa

  • South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site # 31793)

    Worcester, Western Cape, 6850, South Africa

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site # 31802)

    Bangkok, 10330, Thailand

  • University of Cape Town Lung Institute (UCTLI) CRS (Site # 31792)

    Mowbray, Cape Town, Western Cape, 7700, South Africa

More trials for these conditions

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