Trial of SAVVY Vaginal Gel and HIV in Nigeria

Randomized Controlled Trial of SAVVY and HIV in Nigeria

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130078

Enrollment

2142

Registered

2005-08-15

Start date

2004-09-30

Completion date

Unknown

Last updated

2005-09-26

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

Conditions

HIV Infections

Keywords

HIV Seronegativity, HIV transmission

Brief summary

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Detailed description

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Interventions

DRUG1.0% C31G SAVVY vaginal gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 to 35 year old women * HIV negative * More than one sexual partner in past 3 months * Average 3 coital acts per week * Willing to use vaginal gel and condoms for 12 months

Exclusion criteria

* HIV positive * Pregnant

Design outcomes

Primary

Measure	Time frame
Combined incidence of HIV-1 and HIV-2	—

Countries

Nigeria

Contacts

Primary ContactPaul Feldblum

pfeldblum@fhi.org919 544-7040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026