New HIV combo pill tested alongside TB treatment in small trial
NCT ID NCT07631897
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will compare two different HIV medication combinations in 60 people who also have active tuberculosis. Participants will receive either a newer drug (Ainuovirine) or a standard one (Efavirenz), along with their TB meds. The goal is to see which regimen better suppresses the HIV virus and improves immune function over 48 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ainuovirine, Lamivudine, Tenofovir, and Efavirenz
- What this could lead to
- If successful, this could show that a newer HIV drug (Ainuovirine) works as well or better than the standard (Efavirenz) when taken alongside TB treatment, offering a safer or more effective option for co-infected patients.
- What could go wrong
- This is a small, early-stage (Phase 4) study with only 60 participants, so results may not apply to everyone. Drug interactions or side effects could still cause problems.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 to 65 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: * Aged between 18 and 65 years; * Body weight ≥ 40 kg with BMI ranging from 18.5 to 30 kg/m²; * Treatment-naïve patients with HIV-1 infection who are planned to initiate antiretroviral therapy; * Diagnosed with active Mycobacterium tuberculosis infection and receiving anti-tuberculosis regimen containing rifampicin and isoniazid; * CD4⁺ T cell count ≥ 25 cells/μL; * HIV RNA viral load \< 500,000 copies/mL; * Subjects who can fully understand the nature, methods and potential adverse reactions of this trial, comply with the requirements stated in the informed consent form, and voluntarily sign the informed consent form. Exclusion Criteria: * Subjects with allergic constitution or a history of allergy to the study drugs and excipients; * Those with a history of drug addiction, substance abuse, or chronic alcoholism; * Pregnant or lactating women; women of childbearing potential who cannot adopt effective contraceptive measures (e.g., contraceptive diaphragm, condom, intrauterine device, partner vasectomy), or whose sexual partners fail to implement effective contraception; * Subjects who have used drugs with moderate to high drug drug interaction potential with the study drugs (excluding anti tuberculosis drugs) within 2 weeks prior to formal enrollment and ART initiation (only applicable to the pre trial phase); * Those who are unable to receive oral anti tuberculosis treatment during antiretroviral therapy; * Subjects with baseline drug resistance test results showing resistance to NNRTIs, 3TC or TDF; * Those with resistance to one or more anti tuberculosis drugs; * Subjects diagnosed or tentatively diagnosed with tuberculous meningitis; * Patients complicated with other severe opportunistic infections besides Mycobacterium tuberculosis infection; * Abnormal liver function: alanine transaminase (ALT)/aspartate transaminase (AST) \> 3×ULN with clinical symptoms, or \> 5×ULN without symptoms; total bilirubin (TBil) \> 2×ULN; * Impaired renal function: estimated glomerular filtration rate (eGFR) calculated by the CKD EPI formula \< 60 mL/min/1.73 m²; * Subjects complicated with tumors, severe neurological or psychiatric diseases, metabolic disorders, gastrointestinal diseases or other comorbidities that, in the investigator's judgment, may affect their participation and completion of the study; * Any other conditions deemed inappropriate for enrollment by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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