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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002184 |
Purpose
To evaluate the safety and tolerance of the combination of adefovir dipivoxil at two comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or stavudine (Group 2) vs. the combination of adefovir dipivoxil and saquinavir SGC plus either zidovudine, lamivudine, or stavudine (Group 3) in HIV-infected patients with prior nucleoside reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have CD4 cell counts >= 100 cells/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (<500 copies/ml) at 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil Drug: Saquinavir Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 100/mm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies/Ml and Prior RTI Therapy But No Prior PI Therapy |
| Estimated Enrollment: | 120 |
This protocol is a stratified, randomized, double-blind, dose-comparative study of the safety and efficacy of adefovir dipivoxil in combination with nelfinavir and saquinavir soft gel capsules (SGC) or adefovir dipivoxil in combination with nelfinavir or saquinavir SGC plus a nucleoside analog (zidovudine, lamivudine, or stavudine).
Patients will be randomized to adefovir dipivoxil with nelfinavir and saquinavir or adefovir dipivoxil with nelfinavir or saquinavir plus a nucleoside analog (zidovudine, lamivudine, or stavudine). Within each treatment arm, patients will be randomized to 1 of 2 doses of adefovir dipivoxil in a blinded manner. Patients randomized to receive a nucleoside analog will then be assigned to receive either zidovudine, lamivudine, or stavudine based upon their previous RTI therapy. A daily dose of L-carnitine will be administered to all patients.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
Patients with any of the following prior conditions are excluded:
Significant history of peripheral neuropathy.
1. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
Ritonavir, indinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.
1. Prior use of adefovir dipivoxil.
Required:
Prior therapy for > 4 weeks with any licensed nucleoside analog inhibitor of HIV reverse transcriptase.
Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
Contacts and Locations| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| UCLA Care Ctr | |
| Los Angeles, California, United States, 900951793 | |
| Krauss Med Partners / Dept of Research and Development | |
| Los Angeles, California, United States, 90036 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| United States, Connecticut | |
| Blick Med Associates | |
| Greenwich, Connecticut, United States, 06830 | |
| United States, District of Columbia | |
| George Washington Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Maryland | |
| Johns Hopkins Univ School of Medicine | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New York | |
| North Shore Community Hosp | |
| Manhassett, New York, United States, 11030 | |
| United States, Oklahoma | |
| Associates of Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Mem Hosp of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Puerto Rico | |
| Hosp Regional de Ponce - Area Vieja | |
| Ponce, Puerto Rico, 00731 | |
| San Juan AIDS Program | |
| Santruce, Puerto Rico, 00908 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002184 History of Changes |
| Other Study ID Numbers: | 232E |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Dose-Response Relationship, Drug Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count |
Lamivudine RNA, Viral Saquinavir Nelfinavir Reverse Transcriptase Inhibitors Adenine Anti-HIV Agents Viral Load |
|
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 Carnitine Protease Inhibitors Saquinavir Nelfinavir |
Zidovudine Stavudine Adefovir dipivoxil Adefovir Lamivudine Reverse Transcriptase Inhibitors HIV Protease Inhibitors Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |