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Antiviral agents Tenofovir for prevention of emerging HIV infections among MSM population: an open, randomized, multi center, paralleled controlled trial

Antiviral agents Tenofovir for prevention of emerging HIV infections among MSM population: an open, randomized, multi center, paralleled controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003849
Enrollment
Unknown
Registered
2013-06-24
Start date
2013-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

AIDS

Interventions

A: Time-driven group:Tenofovir 300mg p.o. qd for 96 wks
B: Event-driven group:Tenofovir 300mg p.o. at 48-24 hrs before sex and another 300mg po 2h after sex
C: Control:No drug and Standard HIV prevention intervention services provided as other groups

Sponsors

National Base for Drug Clinical Trials, First Affiliated Hospital, Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Signed informed consent; (2) Aged 18 to 65 years; (3) Anti-HIV Negative; (4) Sexual behaviour: An average of once every two weeks or more; (5) One before before trial, has one or more same-sex-partner; (6) Compliance to guidance of drug use and follow-up; (7) Accept to participate in trial for 96 weeks.

Exclusion criteria

Exclusion criteria: (1) Anti-HIV: Postive in screening; (2) HBsAg or anti-HBc: Positive in screening; (3) With severe heart diseases, liver diseases(AST, ALT more than 1.5 times to the upper limit of normal), kidney disorders(BUN, Cr exceed the upper limit of normal) or hematopoietic dysfunction disorders, bleeding tendency and hemorrhagic disease patients; (4) With advanced cancer; (5) Alcoholism within 1 year; (6) With serious diseases that the researchers believe inappropriate to include; (7) Received other related drugs within 3 months; (8) With severe allergies; (9) Unable or unwilling to provide informed consent or who can not comply with the guidance.

Design outcomes

Primary

MeasureTime frame
HIV-1 Antibody;HIV-2 Antibody;

Secondary

MeasureTime frame
Blood routine examination;Urinary routine examination;Blood biochemistry examination;Plasma HIV RNA;CD4 cell count;

Countries

China

Contacts

Public ContactAilong Huang

Chongqing Medical University

wenxiang_huang@163.com+86 023-89012430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026