Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Tenofovir Disoproxil Fumarate	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV – An Extended Safety Evaluation

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Formic acid Tenofovir Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by FHI 360:

Primary Outcome Measures:

To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men

Secondary Outcome Measures:

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


Estimated Enrollment:	500

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

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: NCT00122512

Locations


Malawi
UNC Project, Kamuzu Central Hospital
Lilongwe, Malawi

Sponsors and Collaborators

FHI 360

Investigators


Principal Investigator:	Irving Hoffman, PA, MPH	UNC Center for Infectious Diseases

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00122512 History of Changes
Other Study ID Numbers:	9876
Study First Received:	July 19, 2005
Last Updated:	February 9, 2006
Health Authority:	United States: Institutional Review Board

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

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:


Tenofovir Tenofovir disoproxil Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015