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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; TB - Tuberculosis; Art Therapy
• Intervention / Treatment: Drug: Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets; Drug: Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Chen; Phone Number: 021-37990333; Email: chenjun@shaphc.org
• Study Contact Backup: Name: Ling Gu; Phone Number: 021-37990333; Email: guling@shaphc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TLE group; 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.	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.
Experimental: ALT group; 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral suppression rates of two antiretroviral therapy(ART) regimens at week 48	Percentage of HIV RNA virological suppression (HIV RNA viral load <50 copies/mL) in two groups treated with Ainuovirine-based regimen or TLE regimen for 48 weeks	at week 48

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Latent Infection; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Latent Tuberculosis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Organophosphorus Compounds; Nucleosides; Deoxyribonucleosides; Organophosphonates; Adenine; Dideoxynucleosides; Zalcitabine; Tenofovir; Lamivudine
• Other Study ID Numbers: 2026-S031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No