Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: daily TDF/FTC; Placebo
Intervention description: daily oral medication; daily oral medication
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2499.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; Chemoprophylaxis; Hepatitis; Viral human hepatitis; HIV Seronegativity

Summary:

      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).
    

Eligibility 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