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

Tracking Information
First Received Date ^ICMJE	January 24, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection
Official Title ^ICMJE	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
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Tenofovir disoproxil fumarate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002453
Responsible Party
Study ID Numbers ^ICMJE	283C, GS-99-908
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP