Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Information source: University of Washington
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1 Infections; HIV Infections
Intervention: Tenofovir Disoproxil Fumarate (TDF) (Drug); Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Connie Celum,, MD, MPH, Study Chair, Affiliation: University of Washington
Jared Baeten, MD, PhD, Study Director, Affiliation: University of Washington
Overall contact:
Connie Celum, MD, MPH, Phone: 206-520-3825, Email: ccelum@u.washington.edu
Summary
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.
Clinical Details
Official title: Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexual HIV-1 discordant couples.Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF to those randomized to placebo.
Secondary outcome: Reported risk behaviours, STI prevalence, pill counts and reported adherence.HIV-1 drug resistance, plasma HIV-1 RNA levels and CD4 T cell counts among HIV-1 seroconverters. Congenital abnormalities, growth and development among infants born to female participants taking study drug.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria for HIV-1 uninfected partner:
- Partner within an HIV-1 discordant heterosexual relationship
- One partner meets study eligibility for HIV-1 uninfected study participant and the
other partner meets study eligibility criteria for HIV-1 infected participant
- Plan to remain in the relationship for the duration of the study period
- Adequate renal, hepatic & hematologic function
- Negative Hepatitis B surface antigen test
- Willing and able to provide written informed consent & locator information
Exclusion Criteria for HIV-1 uninfected partner:
- Current pregnancy, or planning to become pregnant during the study period
- Currently breastfeeding
- Concurrent enrollment in another HIV-1 vaccine or prevention trial
- Receiving ongoing antiretroviral therapy
- Repeated positive urine dipstick tests for glycosuria or proteinuria
- Active and serious infections
- History of pathological bone fractures not related to trauma
Inclusion Criteria for HIV-1 infected partner:
- Partner within an HIV-1 discordant heterosexual relationship
- One partner meets study eligibility for HIV-1 uninfected study participant and the
other partner meets study eligibility criteria for HIV-1 infected participant
- HIV-1 infected based on positive EIA
- No history of any clinical AIDS-defining diagnoses
- Plan to remain in the relationship for the duration of the study period
- Willing and able to provide written informed consent & locator information
Exclusion Criteria for HIV-1 infected partner:
- Current use of antiretroviral therapy
- Concurrent enrollment in another HIV-1 treatment trial
Locations and Contacts
Connie Celum, MD, MPH, Phone: 206-520-3825, Email: ccelum@u.washington.edu
Moi University - Indiana University, Eldoret, Kenya; Recruiting
Cosmas Apaka, Phone: 254 53 206 0786, Email: cosmasapaka@gmail.com
Edwin Were, MBChB, MMed, MPH, Phone: 254 733 759 942, Email: ewere@africaonline.co.ke
Ken Fife, MD, PhD, Principal Investigator
Edwin Were, MBChB, MMed, MPH, Principal Investigator
CMR, Kemri-UCSF, Kisumu, Kenya; Recruiting
Josephine B. Odoyo, Phone: 254572021036, Email: orajose@kemri-ucsf.org
Craig Cohen, MD, MPH, Principal Investigator
Elizabeth Bukusi, MD, MPH, Principal Investigator
Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya; Recruiting
James N Kiarie, MBChB, MMed, MPH, Phone: 254 733 771 288, Email: Jkiarie@swiftkenya.org
Grace John-Stewart, MD, PhD, Principal Investigator
Carey Farquhar, MD, MPH, Principal Investigator
James Kiarie, MBChBM MMed, MPH, Principal Investigator
Partners in Prevention - Thika, Thika, Kenya; Recruiting
Kenneth Ngure, BSN, MPH, Phone: 254 67 21305, Ext: 22561, Email: kngure@pipsthika.org
Nelly Mugo, MD, MPH, Principal Investigator
Kabwohe Clinical Research Center, Bushenyi, Uganda; Recruiting
Stephen Asiimwe, MD, Phone: 256 772 479 062, Email: asiimwes@yahoo.com
Elioda Tumwesigye, MD, MS, Principal Investigator
Infectious Diseases Institute, Jinja, Uganda; Recruiting
Paul Muwanguzi, MBChB, Phone: +256-772-359286, Email: paulmark011@yahoo.com
Elly Katabira, MD,FRCP, Principal Investigator
Patrick Ndase, MBChB, MPH, Principal Investigator
Partners House-Infectious Disease Institute Ltd, Kampala, Uganda; Recruiting
Edith Nakku, MBChB, PhD, Phone: 256 772 682 846, Email: edith.nakkujoloba@gmail.com
Elly Katabira, MD, FRCP, Principal Investigator
Allan Ronald, MD, Principal Investigator
The AIDS Support Organization (TASO), Mbale, Uganda; Recruiting
Akasiima Mucunguzi, MBChB, Phone: 256 772 534 626, Email: makasiima@yahoo.com
Jonathan Wangisi, MBChB, Phone: 256 774 327 077, Email: jwangisi@yahoo.com
Jordan Tappero, MD, MPH, Principal Investigator
The AIDS Support Organization - Tororo Field Station, Tororo, Uganda; Recruiting
. Aloysious Kakia, MBChB, Phone: 256 755 588 607, Email: kakialozio@yahoo.co.uk
Christine Nabiryo, MBChB, Phone: 256 772 619 148, Email: cnabiryo@yahoo.com
Jordan Tappero, MD, MPH, Principal Investigator
James Campbell, MD, Principal Investigator
Additional Information
Starting date: May 2008
Last updated: February 11, 2010
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