Botswana Tenofovir Oral HIV Prophylaxis Trial
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ClinicalTrials.gov Identifier: NCT00111150 |
Recruitment Status
:
Terminated
(Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial)
First Posted
: May 18, 2005
Last Update Posted
: March 19, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Tenofovir Disoproxil Fumarate 300 mg daily | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | September 2005 |
Actual Study Completion Date : | March 2007 |

- Adverse drug reactions in the tenofovir and placebo arms
- HIV incidence in the tenofovir and placebo arms
- Changes in levels of unprotected sex during the trial
- Adherence to medication
- Antiretroviral (ARV) resistance patterns in seroconverters
- Viral set point in seroconverters

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Ages Eligible for Study: | 18 Years to 29 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111150
United States, Georgia | |
Centers for Disease Control and Prevention | |
Atlanta, Georgia, United States, 30333 | |
Botswana | |
BOTUSA HIV Prevention Research Unit | |
Francistown and Gaborone, Botswana |
Study Chair: | Dawn K Smith, MD, MS, MPH | CDC and BOTUSA | |
Study Chair: | Lynn A Paxton, MD, MPH | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00111150 History of Changes |
Other Study ID Numbers: |
CDC-NCHSTP-4321 BOTUSA MB04 |
First Posted: | May 18, 2005 Key Record Dates |
Last Update Posted: | March 19, 2007 |
Last Verified: | March 2007 |
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 |