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

NCT00078182 | Withdrawn Phase 2

• 1 other identifier: 1U01AI054241-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; HIV Seronegativity

Keywords

HIV Prevention

Interventions

Tenofovir DF DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• NCHADS - Ministry of Health of Cambodia: collaborator
• Kirby Institute: collaborator

Study Sites (1)

NCAHDS

Phnom Penh, Cambodia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kimberly Shafer, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 19, 2004
• First Posted: February 20, 2004
• Last Updated: December 14, 2016

Record last verified: 2005-05

Locations

CA (1)