Clinical Trials

MainTitle

Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

This study has been terminated
Sponsor
FHI 360


Information provided by (Responsible Party)
FHI 360
ClinicalTrials.gov Identifier
NCT00122512

First received: July 19, 2005
Last updated: February 9, 2006
Last Verified: February 2006
History of Changes
Purpose

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
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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes 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

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

More Information


Responsible Party: FHI 360  
ClinicalTrials.gov Identifier: NCT00122512   History of Changes  
Other Study ID Numbers: 9876  
Study First Received: July 19, 2005  
Last Updated: February 9, 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
Tenofovir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.