Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
Verified November 2001
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: February 9, 2001
Last updated: June 23, 2005
Last Verified: November 2001
History of Changes
The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing.
Drug : Tenofovir disoproxil fumarate
Primary Purpose: Treatment
|Official Title:||US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||February 2001|
Patients receive daily doses of tenofovir DF.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) of at least 10,000 copies/ml by PCR within the previous 2 months.
- Have a CD4 count of 100 cells/mm3 or lower within the previous 2 months. Patients with a CD4 count above 100 and as high as 200 cells/mm3 may also be eligible if they had an opportunistic (AIDS-related) infection within the past 90 days.
- Have failed treatment with at least 2 protease inhibitors (PIs) or at least 1 PI plus a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- Are not able to get effective treatment with a combination of currently approved anti-HIV drugs.
- Are at least 18 years old.
- Have a negative serum pregnancy test.
- Are willing to use a barrier method of birth control (both males and females) while on the study and for 30 days after taking the drug.
- Have or have had kidney disease or bone disease.
- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
- Are taking, or have taken within 7 days of enrolling in the study, adefovir dipivoxil or drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, foscarnet, intravenous (IV) amphotericin B, IV pentamidine, IV vancomycin, and chemotherapy (e.g., cisplatin).
- Have any medical conditions or have had any medications that the study investigator
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011089
Locations Show More
|United States, California|
|Foster City, California, United States, 94404|
Sponsors and CollaboratorsGilead Sciences
|Responsible Party:||Gilead Sciences|
|ClinicalTrials.gov Identifier:||NCT00011089 History of Changes|
|Other Study ID Numbers:||283G|
|Study First Received:||February 9, 2001|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:HIV-1
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.