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

Official title

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

Overview

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.

Interventions

• Drug Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
  Antiretroviral therapy is initiated 14 days after participants receive anti-tuberculosis treatment with rifampicin and isoniazid. The regimen is Ainuovirine 150mg, Lamivudine 300mg and Tenofovir 300mg, one tablet each time, once daily.
• Drug Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets
  Antiretroviral therapy is initiated 14 days after participants receive anti-tuberculosis treatment consisting of rifampicin and isoniazid. The regimen is Efavirenz 400 mg, Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg, one tablet of each taken once daily.

Primary outcome measures

• Viral suppression rates of two antiretroviral therapy(ART) regimens at week 48 [Time frame: at week 48]

Secondary outcome measures (5)

• Immunological efficacy (CD4+ T cell count) of the two groups at week 48 [Time frame: at week 48]
• ART treatment failure rate of the two groups [Time frame: at week 48]
• Evaluate the anti-tuberculosis treatment outcomes of two groups, with primary indicators of cure rate and treatment failure rate [Time frame: at week 48]
• Incidence rates of all-grade adverse events and grade ≥3 adverse events in the two groups [Time frame: through study completion, about 48 weeks]
• Types and constituent ratios of adverse events above grade 1 in the two groups [Time frame: through study completion, about 48 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07631897 · 2026-S031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗