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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00002453. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
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
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 ^†	Interventional
Study Design ^†	Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Tenofovir disoproxil fumarate
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	300
Start Date ^†	December 1999
Completion Date
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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002453
Organization ID	283C
Secondary IDs ^††	GS-99-908
Study Sponsor ^†	Gilead Sciences
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 2000
First Received Date ^†	January 24, 2000
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.