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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tenofovir disoproxil fumarate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tenofovir Coordinating Center

Foster City, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GS-99-908

Identifier Type: -

Identifier Source: secondary_id

283C