Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Kirby Institute; NCHADS - Ministry of Health of Cambodia
• Treatments: Tenofovir

Criteria

Inclusion Criteria

• HIV uninfected

• Report receiving money or gifts for vaginal or anal sexual intercourse in the year prior to study entry

• Able to provide a street address of residence for themselves and two personal contacts who would know their whereabouts during the study period

• Normal lab values within 14 days of study entry

• Ability to understand spoken Khmer

• Willing and able to provide written informed consent

Exclusion Criteria

• Pregnant or breast-feeding

• Previously diagnosed active or serious infections

• Certain medications

• Active alcohol or drug abuse that could interfer with the study

• Previously diagnosed malignancies other than basal cell carcinoma

• Any other condition that, in the opinion of the study officials, would preclude informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives