The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 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:
NCT00007436
First received: December 19, 2000
Last updated: June 23, 2005
Last verified: July 2001
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Purpose
The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tenofovir disoproxil fumarate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Have completed another study on tenofovir DF without toxicity.
- Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
- Are taking agents that affect kidney function, such as probenecid.
- Are receiving systemic chemotherapy.
- Are taking systemic corticosteroids.
- Are taking experimental drugs except those that are approved by Gilead.
- Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
- Are pregnant or breast-feeding.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007436
Locations
| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| Pacific Horizons Med Group | |
| San Francisco, California, United States, 94115 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Univ of Colorado / Health Science Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Physicans Home Service | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Steinhart Medical Associates | |
| Miami, Florida, United States, 33133 | |
| Dr Gerald Pierone Jr | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Illinois | |
| Northstar Med Clinic | |
| Chicago, Illinois, United States, 60657 | |
| United States, Massachusetts | |
| CRI New England | |
| Brookline, Massachusetts, United States, 02146 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| United States, Oregon | |
| Research & Education Group | |
| Portland, Oregon, United States, 97209 | |
| United States, Pennsylvania | |
| Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 17033 | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15221 | |
| United States, Rhode Island | |
| Roger Williams Med Ctr | |
| Providence, Rhode Island, United States, 02908 | |
| United States, Texas | |
| Southwest Infectious Diseases Associates | |
| Dallas, Texas, United States, 75246 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| United States, Washington | |
| Dr Philip C Craven | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Gilead Sciences
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00007436 History of Changes |
| Other Study ID Numbers: | 283F, GS-99-910 |
| Study First Received: | December 19, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination 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 Anti-Retroviral Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013