HIVPhase 4ALT VS TLENCT07631897

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

A Phase 4 study testing Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets and Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets in people with HIV and Art Therapy, run by Shanghai Public Health Clinical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV, Art Therapy, TB - Tuberculosis
What is being tested?: Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets and Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Jun 2026to Dec 2028
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jun Chen contact

Ling Gu contact

About this study

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

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.

Conditions: HIV, Art Therapy, TB - Tuberculosis
Being tested: Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets
Medical subject headings: Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate TabletsDrug
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.
Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate TabletsDrug
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.

Study groups in NCT07631897
Study group	Role	What they receive
TLE group	Active comparator	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. Receives: Drug: Tenofovir, Lamivudine and Efavirenz Disoproxil Fumarate Tablets
ALT group	Experimental	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. Receives: Drug: Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: at week 48

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2026Dec 2028

First posted8 Jun 2026
Study startJun 2026 (estimated)
Primary completionJun 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07631897
Sponsor's protocol ID: 2026-S031
Acronym: ALT VS TLE
Status last verified: Jun 2026
First submitted: 25 May 2026
Last updated: 8 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Jun Chen

021-37990333

chenjun@shaphc.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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