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
Recruitment status was Active, not recruiting
Sponsor:
Gilead Sciences
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00011089
First received: February 9, 2001
Last updated: June 23, 2005
Last verified: November 2001
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Tenofovir disoproxil fumarate |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00011089 History of Changes |
| Other Study ID Numbers: | 283G, GS-00-955 |
| Study First Received: | February 9, 2001 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Disease Progression Reverse Transcriptase Inhibitors Anti-HIV Agents 9-(2-phosphonylmethoxypropyl)adenine |
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 Reverse Transcriptase Inhibitors |
Tenofovir Tenofovir disoproxil Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 22, 2013