Botswana Tenofovir Oral HIV Prophylaxis Trial - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborators:	Botswana Ministry of Health Gilead Sciences
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00111150

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 II Phase III

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

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

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

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

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:

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 disoproxil

Tenofovir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012