Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was Active, not recruiting
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: February 9, 2001
Last updated: June 23, 2005
Last verified: November 2001
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
||US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options
| Study Start Date:
Patients receive daily doses of tenofovir DF.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Patients will not be eligible for this study if they:
- 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 believes will make him/her unsuitable for the study.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011089
|Foster City, California, United States, 94404 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 9, 2001
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors