Botswana Tenofovir Oral HIV Prophylaxis Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

May 17, 2005

Last Updated Date

March 16, 2007

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Adverse drug reactions in the tenofovir and placebo arms
HIV incidence in the tenofovir and placebo arms

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00111150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Botswana Tenofovir Oral HIV Prophylaxis Trial

Official Title ^ICMJE

Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

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.

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: Tenofovir Disoproxil Fumarate 300 mg daily

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

1200

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 29 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Botswana

Administrative Information

NCT ID ^ICMJE

NCT00111150

Responsible Party

Study ID Numbers ^ICMJE

CDC-NCHSTP-4321, BOTUSA MB04

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Botswana Ministry of Health
Gilead Sciences

Investigators ^ICMJE

Study Chair:	Dawn K Smith, MD, MS, MPH	CDC and BOTUSA
Study Chair:	Lynn A Paxton, MD, MPH	Centers for Disease Control and Prevention

Information Provided By

Centers for Disease Control and Prevention

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP