Trial of SAVVY and HIV in Ghana

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

2004-01-31

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 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 of 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

Principal Investigators

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Leigh Peterson, PhD

Role: STUDY_CHAIR

FHI 360

Locations

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Noguchi Memorial Institute for Medical Research/University of Ghana

Accra, , Ghana

Site Status

Komfo Anokye Teaching Hospital/Kwame Nkrumah University of Science and Technology

Kumasi, , Ghana

Site Status

Countries

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Ghana

References

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Peterson L, Nanda K, Opoku BK, Ampofo WK, Owusu-Amoako M, Boakye AY, Rountree W, Troxler A, Dominik R, Roddy R, Dorflinger L. SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS One. 2007 Dec 19;2(12):e1312. doi: 10.1371/journal.pone.0001312.

Reference Type DERIVED

PMID: 18091987 (View on PubMed)

Other Identifiers

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9779

Identifier Type: -

Identifier Source: org_study_id