Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00458393

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2499

Starts

2007-06-01

Expected to finish

2014-02-01

Last updated by the study team

2021-11-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco Dept. of Public Health iPrEx CRS — San Francisco, California, United States
• Stroger Hospital of Cook County/Core Center IPREX CRS — Chicago, Illinois, United States
• Fenway Community Health iPrEx CRS — Boston, Massachusetts, United States
• IPEC/FIOCRUZ iPrEx CRS — Rio de Janeiro, Brazil
• Projeto Praca Onze, Universidade Federal do Rio de Janeiro iPrEx CRS — Rio de Janeiro, Brazil
• Universidade de Sao Paulo iPrEx CRS — São Paulo, Brazil
• Fundación Ecuatoriana Equidad, Guayaquil, iPrEx CRS — Guayaquil, Guayas, Ecuador
• Asociación Civil Selva Amazónica, Iquitos, iPrEx CRS — Iquitos, Maynas, Peru
• Investigaciones Médicas en Salud (INMENSA), Lince, iPrEx CRS — Lima, Peru
• Desmond Tutu HIV Ctr. iPrEx CRS — Cape Town, South Africa
• Research Institute for Health Sciences iPrEx CRS — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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