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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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:	4700
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
Active Comparator: I	Drug: Tenofovir Disoproxil Fumarate (TDF) TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily. Other Name: Viread + Placebo Truvada
Active Comparator: 2	Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily Other Name: Truvada + Placebo Viread
Placebo Comparator: 3 Placebo TDF + Placebo FTC/TDF orally, once daily.	Drug: Placebo Placebo TDF & Placebo FTC/TDF, 1 tablet each daily. Other Name: Placebo + Placebo

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

Locations

Kenya
Moi University - Indiana University
Eldoret, Kenya
CMR, Kemri-UCSF
Kisumu, Kenya
Kenyatta National Hospital/University of Nairobi
Nairobi, Kenya
Partners in Prevention - Thika
Thika, Kenya
Uganda
Kabwohe Clinical Research Center
Bushenyi, Uganda
Infectious Diseases Institute
Jinja, Uganda
Partners House-Infectious Disease Institute Ltd
Kampala, Uganda
The AIDS Support Organization (TASO)
Mbale, Uganda
The AIDS Support Organization - Tororo Field Station
Tororo, Uganda

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:	Connie Celum MD MPH, University of Washington
ClinicalTrials.gov Identifier:	NCT00557245 History of Changes
Other Study ID Numbers:	32528-A, IND 75,365;, 07-7454-A-01
Study First Received:	November 8, 2007
Last Updated:	December 3, 2010
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir disoproxil

Tenofovir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012