Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
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ClinicalTrials.gov Identifier: NCT00011089 |
Recruitment Status
: Unknown
Verified November 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Tenofovir disoproxil fumarate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Start Date : | February 2001 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011089
United States, California | |
Medical Information | |
Foster City, California, United States, 94404 |
ClinicalTrials.gov Identifier: | NCT00011089 History of Changes |
Other Study ID Numbers: |
283G GS-00-955 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | November 2001 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |