Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
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ClinicalTrials.gov Identifier: NCT00122512 |
Recruitment Status
:
Terminated
First Posted
: July 22, 2005
Last Update Posted
: February 10, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Tenofovir Disoproxil Fumarate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV – An Extended Safety Evaluation |

- To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men
- To evaluate the feasibility (i.e. accrual, retention, adherence, change in behavior) of conducting a large scale trial of TDF for HIV prevention in men recruited from a resource-limited setting
- To assess the preliminary effectiveness of TDF in preventing HIV infection among men at high risk for HIV

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
- Be willing and able to give informed consent
- Be 18 years or older
- Be willing to use study product as directed
- Be willing to adhere to follow-up schedule
- Be willing to participate in the study for up to 12 months
- Be in general good health (no active, serious infections that require parenteral antibiotics, no active clinically significant medical conditions, including heart disease, diabetes, asthma, alcoholism, and cancer)
-
Meet at least one of these three high risk criteria: *Sex with sex worker/bar girl in last 3 months;
- Sex with 2 or more women in last 3 months;
- Sexually transmitted disease (STD) in last 3 months
- Have absence of HIV antibodies by rapid test (at screening and enrollment visit)
- Have absence of hepatitis B (HB) surface antigen (sAg)
- Have adequate renal function (serum creatinine <1.5 mg/dL)
- Have adequate liver function (hepatic transaminases (ALT <54 U/L and AST<46 U/L)
- Have adequate serum phosphorus (>2.2 mg/dL)
- Not be intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area
- Not be receiving an experimental HIV vaccine

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): NCT00122512
Malawi | |
UNC Project, Kamuzu Central Hospital | |
Lilongwe, Malawi |
Principal Investigator: | Irving Hoffman, PA, MPH | UNC Center for Infectious Diseases |
ClinicalTrials.gov Identifier: | NCT00122512 History of Changes |
Other Study ID Numbers: |
9876 |
First Posted: | July 22, 2005 Key Record Dates |
Last Update Posted: | February 10, 2006 |
Last Verified: | February 2006 |
Keywords provided by FHI 360:
AE adverse event AIDS acquired immunodeficiency syndrome ALT (SGPT) alanine aminotransferase ART antiretroviral therapy AST (SGOT) aspartate aminotransferase DCF data collection forms DMC Data Monitoring Committee FDA (U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines HB sAg Hepatitis B surface antigen ICH International Conference of Harmonisation IND Investigational New Drug Application |
IRB Institutional Review Board IU international units mg milligram(s) mm3 cubic millimeter(s) PCR polymerase chain reaction SAE serious adverse event TDF tenofovir disoproxil fumarate, GS-4331-05, PMPA prodrug µg microgram ULN upper limit of the normal range WB Western Blot Human Immunodeficiency Virus HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System 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 |