Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
This study is currently recruiting participants.
Verified March 2013 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00458393
First received: April 6, 2007
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
Show Detailed Description
The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Placebo |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
Official Title: | Chemoprophylaxis for HIV Prevention in Men |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Anti-HIV seroconversion [ Time Frame: At 36 months ] [ Designated as safety issue: Yes ]
- Safety endpoints, including Grade 1 or higher creatinine toxicity; Grade 3 or higher phosphorous toxicity; Grade 2, 3, or 4 laboratory adverse events; or Grade 2, 3, or 4 clinical adverse events; or HIV seroconversion [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Hepatitis flares among hepatitis B virus (HBV) infected persons during and after chemoprophylaxis [ Time Frame: At 42 months ] [ Designated as safety issue: Yes ]
- Changes in bone mineral density, body fat distribution, or fasting triglyceride and cholesterol levels [ Time Frame: At 42 months ] [ Designated as safety issue: Yes ]
- Among HIV infected participants: viral load, drug resistance, and CD4 count [ Time Frame: At 42 months ] [ Designated as safety issue: Yes ]
- Proportion of missed doses by pill count and by estimate during CASI interview [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
- Risk behavior, including number of sexual partners with HIV positive or unknown status, total number of sexual partners, and condom use before, during, and after use of study medication [ Time Frame: At 42 months ] [ Designated as safety issue: Yes ]
- Prevalence of sexually transmitted infections (STIs) before, during, and after use of study medication [ Time Frame: At 42 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 3000 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: 1
Daily oral emtricitabine/tenofovir disoproxil fumarate
|
Drug: Emtricitabine/tenofovir disoproxil fumarate
Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo Comparator: 2
Daily oral placebo
|
Drug: Placebo
Placebo for emtricitabine/tenofovir disoproxil fumarate
|
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Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male sex (at birth)
- HIV uninfected
- Age having reached the local age of consent
- High risk for HIV infection including any of the following: 1) No condom use during anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 3 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used in the last 6 months.
- Able to provide a street address of residence for themselves and one personal contact who would know their whereabouts during the study period
- Healthy enough to work, as indicated by score of 80 or greater on the Karnofsky scale
- Certain laboratory values
- A urine dipstick with a negative or trace result for both glucose and protein within 28 days of enrollment.
- Ability to understand and local language for which an informed consent form has been approved by a local IRB and registered with the study sponsor.
Inclusion Criteria for Open-Label Extension:
- Participated in a randomized, placebo-controlled, PrEP trail
- Has been unblinded
- Has provided informed consent
Exclusion Criteria:
- Previously diagnosed active and serious infections, including tuberculosis infection, osteomyelitis, or infections requiring parenteral antibiotic therapy
- Active clinically significant medical problems including heart disease (e.g., symptoms of ischemia, congestive heart failure, arrhythmia), lung disease (steroid-dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication, or previously diagnosed cancer expected to require further treatment
- Acute HBV infection at the screening visit or presence of treatment indications for hepatitis B based on local practice standards; or clinical signs of hepatic cirrhosis
- History of pathological bone fractures not related to trauma
- Receiving ongoing therapy with certain HIV/AIDS-related medications or other medications as determined by the investigator
- Definitely or possibly received an anti-HIV vaccine while participating in a blinded clinical trial
- Current alcohol or drug use that, in the opinion of the investigator, may interfere with the study
- Current participation in a clinical trial or cohort study other than sub-studies of this protocol
- Any condition at enrollment that, in the opinion of the investigator, would make participation in the study unsafe or would interfere with the study
- Sites may utilize additional criteria that restrict enrollment to a subset of people who meet the protocol-defined enrollment criteria.
Exclusion Criteria for Open-Label Extension:
- Site leadership believes participant will have difficulty completing requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458393
Contacts
Contact: Robert M. Grant, MD, MPH | 415-734-4810 | robert.grant@ucsf.edu |
Contact: Vanessa M. McMahan, BS | 415-734-4839 | vmcmahan@gladstone.ucsf.edu |
Locations
United States, California | |
San Francisco Dept. of Public Health iPrEx CRS | Recruiting |
San Francisco, California, United States, 94102 | |
Contact: Hailey Gilmore 415-554-8432 hailey.gilmore@sfdph.org | |
UCSF, Gladstone Institute of Virology & Immunology | Not yet recruiting |
San Francisco, California, United States, 94158-2261 | |
United States, Illinois | |
Stroger Hospital of Cook County/Core Center IPREX CRS | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Kelly Bojan, R.N., C.F.N.P. 1-312-572-4571 kbojan@sbcglobal.net | |
United States, Massachusetts | |
Fenway Community Health iPrEx CRS | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Christopher Chianese, B.A., M.Ed. 617-927-6078 cchianese@fenwayhealth.org | |
Brazil | |
IPEC/FIOCRUZ iPrEx CRS | Recruiting |
Rio de Janeiro, Brazil, 21040-900 | |
Contact: Lucilene A. Freitas, R.N. 55-21-22707064 lucilene.freitas@ipec.fiocruz.br | |
Projeto Praca Onze, Universidade Federal do Rio de Janeiro iPrEx CRS | Recruiting |
Rio de Janeiro, Brazil, 21941.590 | |
Contact: Monica Barbosa de Souza 55-21-22739073 monica@ponze.ufrj.br | |
Universidade de Sao Paulo iPrEx CRS | Recruiting |
Sao Paulo, Brazil, 05403 | |
Contact: Zelinda B. Nakagawa 55-11-30697214 zelinda.bartolomei@gmail.com | |
Ecuador | |
Fundación Ecuatoriana Equidad, Guayaquil, iPrEx CRS | Recruiting |
Guayaquil, Guayas, Ecuador | |
Contact: Luis F. Galarza Hinojosa 593-4-2399264 fgalarza@equidadecuador.org | |
Peru | |
Asociación Civil Selva Amazónica, Iquitos, iPrEx CRS | Recruiting |
Iquitos, Maynas, Peru | |
Contact: Jorge Baldeon Rios 51-6-5236277 jbaldeon@acsaperu.org | |
Asociacion Civil Impacta Salud y Educacion, Lince Non-Network CRS | Withdrawn |
Lima, Peru, 14 | |
Asociación Civil Impacta Salud y Educación, San Miguel, iPrEx CRS | Withdrawn |
Lima, Peru, 32 | |
EMETAC Non-Network CRS | Withdrawn |
Lima, Peru, 14 | |
Investigaciones Médicas en Salud (INMENSA), Lince, iPrEx CRS | Recruiting |
Lima, Peru, 14 | |
Contact: Lorena Vargas 51-1-4413993 lvargas@inmensa.org | |
South Africa | |
Desmond Tutu HIV Ctr. iPrEx CRS | Recruiting |
Cape Town, South Africa, 7925 | |
Contact: Christie Heiberg 27-21-6506964 Christie.Heiberg@hiv-research.org.za | |
Thailand | |
Research Institute for Health Sciences iPrEx CRS | Recruiting |
Chiang Mai, Thailand, 50200 | |
Contact: Pongpun Saokhieo, R.N., M.Sc. 66-5-3894190 rhoppnyt@chiangmai.ac.th |
Sponsors and Collaborators
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: | Robert M. Grant, MD, MPH | J. David Gladstone Institutes, University of California San Francisco |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 14, 2013
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00458393 History of Changes |
Obsolete Identifiers: | NCT00350324 |
Other Study ID Numbers: | iPrEx, 10445, 5U01AI06400202, U01 AI064002, Peru PrEP |
Study First Received: | April 6, 2007 |
Last Updated: | March 1, 2013 |
Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Peru: Ministry of Health Peru: Ethics Committee Ecuador: Public Health Ministry Ecuador: Ethics Committee Brazil: Ministry of Health South Africa: Medicines Control Council Thailand: Ministry of Public Health |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Chemoprophylaxis Hepatitis Viral human hepatitis 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 |
Tenofovir disoproxil 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 March 14, 2013