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Botswana Tenofovir Oral HIV Prophylaxis Trial

This study has been terminated.
(Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial)
Sponsor:
Collaborators:
Botswana Ministry of Health
Gilead Sciences
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00111150
First received: May 17, 2005
Last updated: March 16, 2007
Last verified: March 2007
  Purpose

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 Intervention Phase
HIV Infection
Drug: Tenofovir Disoproxil Fumarate 300 mg daily
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Adverse drug reactions in the tenofovir and placebo arms
  • HIV incidence in the tenofovir and placebo arms

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

Estimated Enrollment: 1200
Study Start Date: September 2005
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00111150     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4321, BOTUSA MB04
Study First Received: May 17, 2005
Last Updated: March 16, 2007
Health Authority: United States: Federal Government
Botswana: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 23, 2014