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A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
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, Disease Progression, Anti-HIV Agents

Eligibility Criteria

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

Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load greater than or equal to 10,000 copies/ml. Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.) Are at least 18 years old. Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward. Have a life expectancy of at least one year. Exclusion Criteria You will not be eligible for this study if you: Have a history of a serious kidney or bone disease. Have severe nausea, vomiting, or trouble taking medications by mouth. Are pregnant or breast-feeding. Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine. Are taking any medicines that interfere with kidney functions.

Sites / Locations

  • Tenofovir Coordinating Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2000
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002453
Brief Title
A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection
Official Title
An Open-Label, Multicenter, Compassionate Access 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
May 2000
Overall Recruitment Status
Completed
Study Start Date
December 1999 (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
This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.
Detailed Description
HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

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, Disease Progression, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load greater than or equal to 10,000 copies/ml. Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.) Are at least 18 years old. Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward. Have a life expectancy of at least one year. Exclusion Criteria You will not be eligible for this study if you: Have a history of a serious kidney or bone disease. Have severe nausea, vomiting, or trouble taking medications by mouth. Are pregnant or breast-feeding. Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine. Are taking any medicines that interfere with kidney functions.
Facility Information:
Facility Name
Tenofovir Coordinating Center
City
Foster City
State/Province
California
ZIP/Postal Code
94404
Country
United States

12. IPD Sharing Statement

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A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

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