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A Multi-center Randomized Clinical Trial on BIC/FTC/TAF vs DTG+3TC+TDF in People with HIV Who Experience Virologic Failure in China

A Multi-center Randomized Clinical Trial on BIC/FTC/TAF vs DTG+3TC+TDF in People with HIV Who Experience Virologic Failure in China

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108287
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conversion therapy after failure of antiretroviral therapy in Hiv-Infected patients

Interventions

DTG 3TC TDF treatment group:DTG+3TC+TDF was used as the conversion treatment
BIC/FTC/TAF treatment group:BIC/FTC/TAF was used as the conversion treatment

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old; 2. First-line NNRTIs 2NRTIs regimen treatment >=6 months with two consecutive (>=7 days apart) viral load >=200 copies/mL, or a single viral load greater than 1000 copies/mL. 3. Good compliance (patients with poor adherence, defined as missed doses three or more times within a month, need to be re-evaluated after 4 weeks of enhanced compliance); 4. No INSTIs treatment; 5. Signed informed consent and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Severe abnormal liver function (ALT>=3 times the upper limit of normal value); 3. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m^2 (CKD-EPI formula); 4. Combined with serious opportunistic infections, malignant tumors or mental illnesses, which may affect treatment compliance; 5. Need for anti-tuberculosis therapy; 6. Need for anti-HCV therapy.

Design outcomes

Primary

MeasureTime frame
Viral suppression rate;

Secondary

MeasureTime frame
Immunological indicators;The percentage of participants with plasma HIV-1 RNA levels <50 copies/mL;

Countries

China

Contacts

Public ContactDai Lili

Beijing Youan Hospital, Capital Medical University

lilydaier@163.com+86 10 83997430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 3, 2026