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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002453
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir disoproxil fumarate Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Primary Purpose: Treatment
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 Start Date : December 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002453

United States, California
Tenofovir Coordinating Center
Foster City, California, United States, 94404
Sponsors and Collaborators
Gilead Sciences Identifier: NCT00002453     History of Changes
Other Study ID Numbers: 283C
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Disease Progression
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents