Double-Dose HIV drug shows promise for Co-Infected patients
NCT ID NCT05630872
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.
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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
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30 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- 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: * 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.
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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
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Durban International CRS (Site # 11201)
Wentworth, Durban, 4052, South Africa
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South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site # 31793)
Worcester, Western Cape, 6850, South Africa
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Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site # 31802)
Bangkok, 10330, Thailand
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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.
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- Four weeks vs twelve weeks: can a shorter TB prevention course work?
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a phone app keep young people with HIV engaged in care?
- Massive Real-World database aims to map how chronic diseases interact
- How do HIV drugs behave when kidneys fail? study measures blood levels