Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples - Full Text View

Sponsor:	University of Washington
Collaborator:	Bill and Melinda Gates Foundation
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00557245

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexual HIV-1 discordant couples. [ Time Frame: Up to 24 months-36 months ] [ Designated as safety issue: No ]
Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF to those randomized to placebo. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reported risk behaviours, STI prevalence, pill counts and reported adherence. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: No ]
HIV-1 drug resistance, plasma HIV-1 RNA levels and CD4 T cell counts among HIV-1 seroconverters. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: Yes ]
Congenital abnormalities, growth and development among infants born to female participants taking study drug. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: Yes ]

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
I: Active Comparator	Drug: Tenofovir Disoproxil Fumarate (TDF) TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
2: Active Comparator	Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
3: Placebo Comparator Placebo TDF + Placebo FTC/TDF orally, once daily.	Drug: Placebo Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557245

Contacts

Contact: Connie Celum, MD, MPH	206-520-3825	ccelum@u.washington.edu
Contact: Jared Baeten, MD, PhD	206-520-3825	jbaeten@u.washington.edu

Locations

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
Infectious Diseases Institute	Recruiting
Jinja, Uganda
Contact: Paul Muwanguzi, MBChB +256-772-359286 paulmark011@yahoo.com
Principal Investigator: Elly Katabira, MD,FRCP
Principal Investigator: Patrick Ndase, MBChB, MPH
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
The AIDS Support Organization - Tororo Field Station	Recruiting
Tororo, Uganda
Contact: . Aloysious Kakia, MBChB 256 755 588 607 kakialozio@yahoo.co.uk
Contact: Christine Nabiryo, MBChB 256 772 619 148 cnabiryo@yahoo.com
Principal Investigator: Jordan Tappero, MD, MPH
Principal Investigator: James Campbell, MD
Kabwohe Clinical Research Center	Recruiting
Bushenyi, Uganda
Contact: Stephen Asiimwe, MD 256 772 479 062 asiimwes@yahoo.com
Principal Investigator: Elioda Tumwesigye, MD, MS

Sponsors and Collaborators

University of Washington

Bill and Melinda Gates Foundation

Investigators

Study Chair:	Connie Celum,, MD, MPH	University of Washington
Study Director:	Jared Baeten, MD, PhD	University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Connie Celum MD MPH )
Study ID Numbers:	32528-A, IND 75,365;, 07-7454-A-01
Study First Received:	November 8, 2007
Last Updated:	December 2, 2009
ClinicalTrials.gov Identifier:	NCT00557245 History of Changes
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

Keywords provided by University of Washington:

HIV infection
HIV uninfected partners
Double Blind
Placebo
Seroconversion

TDF
FTC TDF
Safety
HIV Seronegativity

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Tenofovir disoproxil
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010