Who is sponsoring NCT00540605?

NCT00540605 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT00540605 study?

NCT00540605 studies HIV Infections.

What drugs are being tested in NCT00540605?

Interventions: Tenofovir 1% vaginal gel.

What is the status of NCT00540605?

NCT00540605 is currently COMPLETED.

Last reviewed 2021-10-15 · How we verify

Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas

NCT00540605 Phase 1 COMPLETED

A new approach to HIV prevention currently being studied includes the use of topical microbicides, substances that kill microbes. The purpose of this study is to determine the levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are expecting to deliver by cesarean.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	COMPLETED
Enrolment	21
Completion	2010-01

Conditions

HIV Infections

Interventions

Tenofovir 1% vaginal gel

Primary outcomes

Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax) — Throughout study
Endometrial tenofovir levels — At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration
Placental transfer (cord blood tenofovir levels, placental tissue tenofovir levels, and amniotic fluid tenofovir levels) — At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration

Countries

United States