NCT00122512

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

February 10, 2006

Status Verified

February 1, 2006

First QC Date

July 19, 2005

Last Update Submit

February 9, 2006

Conditions

HIV Infections

Keywords

AE adverse eventAIDS acquired immunodeficiency syndromeALT (SGPT) alanine aminotransferaseART antiretroviral therapyAST (SGOT) aspartate aminotransferaseDCF data collection formsDMC Data Monitoring CommitteeFDA (U.S.) Food and Drug AdministrationGCP Good Clinical Practice guidelinesHB sAg Hepatitis B surface antigenICH International Conference of HarmonisationIND Investigational New Drug ApplicationIRB Institutional Review BoardIU international unitsmg milligram(s)mm3 cubic millimeter(s)PCR polymerase chain reactionSAE serious adverse eventTDF tenofovir disoproxil fumarate, GS-4331-05, PMPA prodrugµg microgramULN upper limit of the normal rangeWB Western BlotHuman Immunodeficiency VirusHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

Tenofovir Disoproxil FumarateDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UNC Project, Kamuzu Central Hospital

Lilongwe, Malawi

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Irving Hoffman, PA, MPH

    UNC Center for Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Last Updated

February 10, 2006

Record last verified: 2006-02

Locations

MA(1)