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NCT00002453 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002453
Other study ID # 283C
Secondary ID GS-99-908
Status Completed
Phase N/A
First received January 24, 2000
Last updated June 23, 2005
Start date December 1999

Study information
Verified date May 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tenofovir disoproxil fumarate

Locations
Country Name City State
United States Tenofovir Coordinating Center Foster City California

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

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