Botswana TDF/FTC Oral HIV Prophylaxis Trial - Full Text View

Sponsors and Collaborators:	Centers for Disease Control and Prevention Botswana Ministry of Health Gilead Sciences
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00448669

Purpose

This study will test whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) 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 Infections	Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg daily	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

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

Primary Outcome Measures:

Adverse drug reactions in the tenofovir/emtricitabine and placebo arms;
HIV incidence in the tenofovir/emtricitabine and placebo arms

Secondary Outcome Measures:

Secondary: 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:	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 and emtricitabine (in a single pill) 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 hormonal contraception (females)
living within 1 hours travel of study clinic
pass comprehension test
willing and able to give informed consent

Exclusion Criteria:

18-20 without parent/guardian consent
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: NCT00448669

Contacts

Contact: Lynn A Paxton, MD, MPH	404-639-6124	lap5@cdc.gov
Contact: Poloko Kebaabetswe, PhD	+267-390-1696	kebaabetsweP@bw.cdc.gov

Locations

United States, Georgia
Centers for Disease Control and Prevention	Recruiting
Atlanta, Georgia, United States, 30333
Contact: Lynn A Paxton, MD, MPH 404-639-6124 lap5@cdc.gov
Principal Investigator: Lynn A Paxton, MD, MPH
Sub-Investigator: Roman Gvetadze, MD
Sub-Investigator: Peter Kilmarx, MD
Sub-Investigator: Dawn K Smith, MD, MS, MPH
Sub-Investigator: Clyde Hart, PhD
Botswana
BOTUSA HIV Prevention Research Unit	Recruiting
Francistown and Gaborone, Botswana
Contact: Poloko Kebaabetswe, PhD +267-390-1696 KebaabetsweP@bw.cdc.gov
Principal Investigator: Poloko Kebaabetswe, PhD
Sub-Investigator: Margarett Davis, MD
Sub-Investigator: Peter Fonjungo, PhD

Sponsors and Collaborators

Centers for Disease Control and Prevention

Botswana Ministry of Health

Gilead Sciences

Investigators

Principal Investigator:

Lynn A Paxton, MD, MPH

US Centers for Disease Control and Prevention

More Information

fact sheet on Botswana, Thailand, and US oral prophylaxis trials This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDC-NCHSTP-4940, BOTUSA MB06
Study First Received:	March 16, 2007
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00448669
Health Authority:	United States: Federal Government; Botswana: Ministry of Health

Keywords provided by Centers for Disease Control and Prevention:

HIV incidence
HIV prevention
Tenofovir

Emtricitabine
Botswana
HIV seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Emtricitabine
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009