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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Malawi

Study Type

Interventional

Intervention

Tenofovir Disoproxil Fumarate

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

UNC Project, Kamuzu Central Hospital

Outcomes

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

Full Information

NCT ID

NCT00122512

First Posted

July 19, 2005

Last Updated

February 9, 2006

Sponsor

FHI 360

1. Study Identification

Unique Protocol Identification Number

NCT00122512

Brief Title

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

Official Title

Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV - An Extended Safety Evaluation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2006

Overall Recruitment Status

Terminated

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

FHI 360

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

500 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tenofovir Disoproxil Fumarate

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

To assess the preliminary effectiveness of TDF in preventing HIV infection among men at high risk for HIV

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irving Hoffman, PA, MPH

Organizational Affiliation

UNC Center for Infectious Diseases

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Project, Kamuzu Central Hospital

City

Lilongwe

Country

Malawi

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial