NCT07631897Not yet recruitingPhase 4
Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir Regimens
Comparative Study on Antiviral Efficacy and Safety of Ainuovirine/Lamivudine/Tenofovir Versus Efavirenz/Lamivudine/Tenofovir Regimen in HIV Patients With Active Tuberculosis Infection: A Two-stage Prospective Multicenter Clinical Study
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Shanghai Public Health Clinical Center
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT07631897
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Jun 2026 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- Subjects with baseline drug resistance test results showing resistance to NNRTIs, 3TC or TDF;
Other illness
- 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;
- Those who are unable to receive oral anti tuberculosis treatment during antiretroviral therapy;
- Those with resistance to one or more anti tuberculosis drugs;
- Patients complicated with other severe opportunistic infections besides Mycobacterium tuberculosis infection;
- 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.
Lab values
- 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;
Other
- 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 diagnosed or tentatively diagnosed with tuberculous meningitis;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.