- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00122512
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
February 9, 2006 updated by: FHI 360
Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV - An Extended Safety Evaluation
This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended safety data for high-risk men.
Secondarily, the study will assess the feasibility of conducting the trial and evaluate the preliminary effectiveness of TDF 300 mg as an HIV prevention method when taken once a day.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
TDF has been selected for investigation as prophylaxis against HIV in high-risk men because of its unique pharmacologic profile.
In addition to the convenience of being a once daily single tablet, TDF's safety profile is comparable to placebo among HIV infected persons, it has striking anti-HIV potency, and it has low potential for selection of resistant viruses.
TDF is cleared from the body by the kidneys and is not metabolized by the liver.
Therefore, TDF has limited potential to have pharmacokinetic interactions with other hepatically metabolized drugs.
Each of these properties is necessary given the realities of the intended target populations.
Moreover, initial prevention studies in simian models have provided encouraging results.
Finally, the drug's sponsor is supportive of investigating the potential use of TDF as a preventive, as well as therapeutic agent, will provide TDF for the study, and is willing to make a good faith effort to make TDF available for public health use should it prove to be effective for HIV prevention.
Study Type
Interventional
Enrollment
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lilongwe, Malawi
- UNC Project, Kamuzu Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men
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Secondary Outcome Measures
Outcome Measure |
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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
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To assess the preliminary effectiveness of TDF in preventing HIV infection among men at high risk for HIV
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Irving Hoffman, PA, MPH, UNC Center for Infectious Diseases
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 19, 2005
First Submitted That Met QC Criteria
July 21, 2005
First Posted (Estimate)
July 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 10, 2006
Last Update Submitted That Met QC Criteria
February 9, 2006
Last Verified
February 1, 2006
More Information
Terms related to this study
Keywords
- HIV Seronegativity
- Human Immunodeficiency Virus
- 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
- mg milligram(s)
- mm3 cubic millimeter(s)
- PCR polymerase chain reaction
- SAE serious adverse event
- µg microgram
- ULN upper limit of the normal range
- WB Western Blot
- IU international units
- TDF tenofovir disoproxil fumarate, GS-4331-05, PMPA prodrug
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- 9876 (CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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