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The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 9-(2-phosphonylmethoxypropyl)adenine

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Have completed another study on tenofovir DF without toxicity. Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment. Exclusion Criteria Patients will not be eligible for this study if they: Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir. Are taking agents that affect kidney function, such as probenecid. Are receiving systemic chemotherapy. Are taking systemic corticosteroids. Are taking experimental drugs except those that are approved by Gilead. Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies. Are pregnant or breast-feeding.

Sites / Locations

  • East Bay AIDS Ctr
  • Tower ID Med Associates
  • Pacific Horizons Med Group
  • Harbor - UCLA Med Ctr
  • Univ of Colorado / Health Science Ctr
  • Physicans Home Service
  • Steinhart Medical Associates
  • Dr Gerald Pierone Jr
  • Northstar Med Clinic
  • CRI New England
  • Univ of Minnesota
  • Univ of Rochester Med Ctr
  • Research & Education Group
  • Hershey Med Ctr
  • Anderson Clinical Research
  • Roger Williams Med Ctr
  • Southwest Infectious Diseases Associates
  • Thomas Street Clinic
  • Dr Philip C Craven

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 19, 2000
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00007436
Brief Title
The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients
Official Title
A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2001
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.
Detailed Description
Patients take tenofovir DF in combination with other antiretrovirals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 9-(2-phosphonylmethoxypropyl)adenine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Have completed another study on tenofovir DF without toxicity. Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment. Exclusion Criteria Patients will not be eligible for this study if they: Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir. Are taking agents that affect kidney function, such as probenecid. Are receiving systemic chemotherapy. Are taking systemic corticosteroids. Are taking experimental drugs except those that are approved by Gilead. Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies. Are pregnant or breast-feeding.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Physicans Home Service
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Steinhart Medical Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Dr Gerald Pierone Jr
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
CRI New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02146
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Research & Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Southwest Infectious Diseases Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Dr Philip C Craven
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

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