Trial of SAVVY Vaginal Gel and HIV in Nigeria

NCT ID: NCT00130078

Last Updated: 2005-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV Seronegativity HIV transmission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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1.0% C31G SAVVY vaginal gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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FHI 360

OTHER

Sponsor Role collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

Biosyn

INDUSTRY

Sponsor Role lead

Principal Investigators

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Paul Feldblum

Role: STUDY_CHAIR

FHI 360

Locations

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Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan

Ibadan, , Nigeria

Site Status RECRUITING

Nigerian Institute of Medical Research

Lagos, , Nigeria

Site Status RECRUITING

Countries

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Nigeria

Central Contacts

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Paul Feldblum

Role: CONTACT

Phone: 919 544-7040

Email: [email protected]

Facility Contacts

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Rasheed A Bakare, MBBS,FWACP

Role: primary

Adesina Adeiga, DVM, MSc

Role: primary

References

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Feldblum PJ, Adeiga A, Bakare R, Wevill S, Lendvay A, Obadaki F, Olayemi MO, Wang L, Nanda K, Rountree W. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS One. 2008 Jan 23;3(1):e1474. doi: 10.1371/journal.pone.0001474.

Reference Type DERIVED
PMID: 18213382 (View on PubMed)

Other Identifiers

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9784

Identifier Type: -

Identifier Source: org_study_id