Not Yet RecruitingPhase 4

Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir Regimens

60 participantsStarted 2026-06

Plain-language summary

This is a prospective, multicenter, open-label, parallel-controlled study. The primary objective is to prospectively explore and compare the virological efficacy of Ainuovirine/Lamivudine/Tenofovir and Efavirenz/Lamivudine/Tenofovir regimens combined with rifampicin and isoniazid-based anti-tuberculosis therapy in HIV-infected patients with active tuberculosis. Participants are divided into two groups to compare the virological suppression rate and immunological efficacy between the two antiretroviral regimens. All subjects will receive continuous antiretroviral medication and anti-tuberculosis drugs under medical supervision throughout the study.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Viral suppression rates of two antiretroviral therapy(ART) regimens at week 48

Timeframe: at week 48

Trial details

NCT IDNCT07631897

SponsorShanghai Public Health Clinical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Jun Chen

021-37990333 chenjun@shaphc.org

View on ClinicalTrials.gov More HIV trials