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Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia Clinical research trials and Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia. Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia clinical trial. Test subjects typically receive the most effective healthcare possible for their Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia  Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
For Condition: HIV Seronegativity,HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , NCHADS - Ministry of Health of Cambodia,NCHECR - University of New South Wales, Australia
Synopsis: 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.
Details: Cambodia has one of the highest rates of HIV infection in Southeast Asia. At the end of 2002, HIV infection rates among Cambodian sex workers ranged from 14.8% to 28.8%. Tenofovir DF is a nucleotide reverse transcriptase inhibitor (NRTI) that was licensed for the treatment of HIV-1 infection by the United States Food and Drug Administration (FDA) in October 2001. This randomized clinical trial will determine if a daily oral 300 mg dose of tenofovir DF is safe and effective in preventing HIV-1 infection. This is a collaborative study between the University of California, San Francisco, the University of New South Wales, and the Ministry of Health of Cambodia. Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial. Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months. Participants will be evaluated for rates of HIV infection, adherence to the drug regimen, and changes in risk behaviors. All participants will be monitored throughout the trial for side effects and toxicity. Participants will be involved in the study for 14 months.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 960
Location and Contact Information:
Overall Study Official:
KimberlyShafer, Principal Investigator,
NCAHDS
Phnom Penh, ,
Cambodia
Soleak Sim 12 82 06 92
Additional Information:
Study ID Numbers: 1 U01 AI054241-01;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078182
Other Hiv Seronegativity Studies:
1. A Phase I/II Pilot Study of Simultaneously Administered rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
2. A Collection of Data from Adult AIDS Clinical Trials
3. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir
4. Phase III PEG-Intron in HIV-infected patients
5. A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients with HIV-Associated Kidney Disease
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Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
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