Botswana Tenofovir Oral HIV Prophylaxis Trial
This study has been terminated.
(Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial)
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
First received: May 17, 2005
Last updated: March 16, 2007
Last verified: March 2007
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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 |
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 (Adult) |
| 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
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
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 28, 2016