Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

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