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Sponsors and Collaborators: |
Centre for the AIDS Programme of Research in South Africa Family Health International United States Agency for International Development (USAID) CONRAD |
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Information provided by: | Centre for the AIDS Programme of Research in South Africa |
ClinicalTrials.gov Identifier: | NCT00441298 |
This proposed phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 980 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tenofovir gel Drug: Placebo (Universal HEC placebo) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa |
Estimated Enrollment: | 980 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Tenofovir gel (a reverse transcriptase inhibitor)
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Drug: Tenofovir gel
Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
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2: Placebo Comparator
Universal HEC placebo
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Drug: Placebo (Universal HEC placebo)
Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
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Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal microbicide, in sexually active women at risk for human immunodeficiency virus (HIV) infection in South Africa.
Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir gel with a placebo gel.
Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa
Study Size: 980 women
Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Study Duration: Approximately 30 months in total. Accrual will require approximately 14 months and follow-up will continue until 68 incident HIV infections are observed in the study, which is expected to occur approximately 16 months after the end of the accrual period.
Primary Objective:
To evaluate the effectiveness and safety of a candidate vaginal microbicide, tenofovir gel, when applied intravaginally by women, in preventing sexually transmitted HIV infection.
Secondary Objectives:
Study sites:
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):
South Africa, KwaZulu-Natal | |
CAPRISA eThekwini Clinical Research Site | |
Durban, KwaZulu-Natal, South Africa, 4001 | |
CAPRISA, Vulindlela Clinical Research Site | |
Pietermaritzburg, KwaZulu-Natal, South Africa, 4013 |
Principal Investigator: | Salim S Abdool karim, MBChB, PhD | CAPRISA, University of KwaZulu-Natal |
Principal Investigator: | Quarraisha Abdool Karim, PhD | CAPRISA, University of KwaZulu-Natal |
Responsible Party: | CAPRISA ( Salim S Abdool Karim and Quarraisha Abdool Karim (Co Principal Investigators) ) |
Study ID Numbers: | CAPRISA 004, PHSC study #9946 |
Study First Received: | February 27, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00441298 |
Health Authority: | South Africa: Medicines Control Council |
microbicides safety effectiveness Tenofovir gel |
HIV young women HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |