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Sponsors and Collaborators: |
University of Washington Bill and Melinda Gates Foundation |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00557245 |
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
Condition | Intervention | Phase |
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HIV-1 Infections HIV Infections |
Drug: Tenofovir Disoproxil Fumarate (TDF) Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples |
Estimated Enrollment: | 3900 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator |
Drug: Tenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
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2: Active Comparator |
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
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3: Placebo Comparator
Placebo TDF + Placebo FTC/TDF orally, once daily.
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Drug: Placebo
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
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HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples.
Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention strategy.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for HIV-1 uninfected partner:
Exclusion Criteria for HIV-1 uninfected partner:
Inclusion Criteria for HIV-1 infected partner:
Exclusion Criteria for HIV-1 infected partner:
Contact: Connie Celum, MD, MPH | 206-520-3825 | ccelum@u.washington.edu |
Contact: Jared Baeten, MD, PhD | 206-520-3825 | jbaeten@u.washington.edu |
Kenya | |
Moi University - Indiana University | Recruiting |
Eldoret, Kenya | |
Contact: Cosmas Apaka 254 53 206 0786 cosmasapaka@gmail.com | |
Contact: Edwin Were, MBChB, MMed, MPH 254 733 759 942 ewere@africaonline.co.ke | |
Principal Investigator: Ken Fife, MD, PhD | |
Principal Investigator: Edwin Were, MBChB, MMed, MPH | |
Kenyatta National Hospital/University of Nairobi | Recruiting |
Nairobi, Kenya | |
Contact: James N Kiarie, MBChB, MMed, MPH 254 733 771 288 Jkiarie@swiftkenya.org | |
Principal Investigator: Grace John-Stewart, MD, PhD | |
Principal Investigator: Carey Farquhar, MD, MPH | |
Principal Investigator: James Kiarie, MBChBM MMed, MPH | |
CMR, Kemri-UCSF | Recruiting |
Kisumu, Kenya | |
Contact: Josephine B. Odoyo 254572021036 orajose@kemri-ucsf.org | |
Principal Investigator: Craig Cohen, MD, MPH | |
Principal Investigator: Elizabeth Bukusi, MD, MPH | |
Partners in Prevention - Thika | Recruiting |
Thika, Kenya | |
Contact: Kenneth Ngure, BSN, MPH 254 67 21305 ext 22561 kngure@pipsthika.org | |
Principal Investigator: Nelly Mugo, MD, MPH | |
Uganda | |
The AIDS Support Organization - Tororo Field Station | Recruiting |
Tororo, Uganda | |
Contact: Jonathan Wangisi, MBChB 256 774 327 077 jwangisi@yahoo.com | |
Contact: Christine Nabiryo, MBChB 256 772 619 148 cnabiryo@yahoo.com | |
Principal Investigator: Jordan Tappero, MD, MPH | |
Principal Investigator: James Campbell, MD | |
Partners House-Infectious Disease Institute Ltd | Recruiting |
Kampala, Uganda | |
Contact: Edith Nakku, MBChB, PhD 256 772 682 846 edith.nakkujoloba@gmail.com | |
Principal Investigator: Elly Katabira, MD, FRCP | |
Principal Investigator: Allan Ronald, MD | |
The AIDS Support Organization (TASO) | Recruiting |
Mbale, Uganda | |
Contact: Akasiima Mucunguzi, MBChB 256 772 534 626 makasiima@yahoo.com | |
Contact: Jonathan Wangisi, MBChB 256 774 327 077 jwangisi@yahoo.com | |
Principal Investigator: Jordan Tappero, MD, MPH | |
Kabwohe Clinical Research Center | Recruiting |
Bushenyi, Uganda | |
Contact: Stephen Asiimwe, MD 256 772 479 062 asiimwes@yahoo.com | |
Principal Investigator: Elioda Tumwesigye, MD, MS |
Study Chair: | Connie Celum,, MD, MPH | University of Washington |
Study Director: | Jared Baeten, MD, PhD | University of Washington |
Responsible Party: | University of Washington ( Connie Celum MD MPH ) |
Study ID Numbers: | 07-7454-A-01, IND 75,365 |
Study First Received: | November 8, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00557245 |
Health Authority: | United States: Food and Drug Administration; Kenya: Ethical Review Committee; Kenya: Institutional Review Board; Kenya: Pharmacy and Poisons Board; Kenya: Ministry of Health; Uganda: Ministry of Health; Uganda: National Council for Science and Technology; Uganda: National Drug Authority; Uganda: Research Ethics Committee |
HIV infection HIV uninfected partners Double Blind Placebo Seroconversion |
TDF FTC TDF Safety HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral Emtricitabine 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 |