Who is sponsoring NCT01490671?

NCT01490671 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT01490671 study?

NCT01490671 studies HIV Infections.

What drugs are being tested in NCT01490671?

Interventions: 1% tenofovir gel, Placebo gel.

What is the status of NCT01490671?

NCT01490671 is currently WITHDRAWN.

Last reviewed 2021-10-28 · How we verify

Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy

NCT01490671 Phase 2 WITHDRAWN

Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug tenofovir may reduce the risk of HIV infection in women when used near the time of sexual intercourse. This study will evaluate the safety of 1% tenofovir gel in HIV-uninfected pregnant women and their newborns when the gel is used once a day for a period of 28 days at a designated time during pregnancy.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	WITHDRAWN

Conditions

HIV Infections

Interventions

1% tenofovir gel
Placebo gel

Primary outcomes

Maternal outcomes: Grade 2 or higher adverse events (AEs) in select categories — Measured through participant's last study visit, which will occur 30 days after delivery
Categories include: specific laboratory abnormalities, specific genital/pelvic signs/symptoms, and pregnancy complications
Neonatal outcomes (first 30 days of life): All serious adverse events (SAEs) — Measured through the 30 day follow-up visit