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Botswana Tenofovir Oral HIV Prophylaxis Trial

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ClinicalTrials.gov Identifier: NCT00111150
Recruitment Status : Terminated (Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial)
First Posted : May 18, 2005
Last Update Posted : March 19, 2007
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Tenofovir Disoproxil Fumarate 300 mg daily Phase 2 Phase 3

Detailed Description:
Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial will receive ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
Study Start Date : September 2005
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Adverse drug reactions in the tenofovir and placebo arms
  2. HIV incidence in the tenofovir and placebo arms

Secondary Outcome Measures :
  1. Changes in levels of unprotected sex during the trial
  2. Adherence to medication
  3. Antiretroviral (ARV) resistance patterns in seroconverters
  4. Viral set point in seroconverters

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • citizen of Botswana 18-29 years old
  • sexually active
  • HIV uninfected
  • Hepatitis B and C uninfected
  • Calculated creatinine clearance >= 60 mL/min
  • hemoglobin >= 8 gm/dL
  • ALT and AST <= 2x ULN
  • total bilirubin <= 1.5 mg/dL
  • total serum amylase <= 1.5x ULN
  • Serum phosphorus >= 2.2 mg/dL
  • willing to use effective contraception
  • living within 1 hours travel of study clinic
  • pass comprehension test
  • willing and able to give informed consent

Exclusion Criteria:

  • history of significant renal or bone disease
  • any chronic illness requiring ongoing prescription medication
  • pregnant or breastfeeding
  • planning to move away from site in the next year
  • participating in another HIV prevention or vaccine safety trial
  • any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111150


Locations
United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
Botswana
BOTUSA HIV Prevention Research Unit
Francistown and Gaborone, Botswana
Sponsors and Collaborators
Centers for Disease Control and Prevention
Botswana Ministry of Health
Gilead Sciences
Investigators
Study Chair: Dawn K Smith, MD, MS, MPH CDC and BOTUSA
Study Chair: Lynn A Paxton, MD, MPH Centers for Disease Control and Prevention
More Information

ClinicalTrials.gov Identifier: NCT00111150     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4321
BOTUSA MB04
First Posted: May 18, 2005    Key Record Dates
Last Update Posted: March 19, 2007
Last Verified: March 2007

Keywords provided by Centers for Disease Control and Prevention:
HIV incidence
HIV prevention

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents