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Sponsors and Collaborators: |
Merck Agouron Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002235 |
Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
Condition | Intervention | Phase |
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HIV Infections |
Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Efavirenz |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | A Phase II, 48-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of a Simplified Dosing Regimen of Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor and Protease Inhibitor Naive Patients |
Estimated Enrollment: | 6 |
Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, California | |
Pacific Oaks Med Group | |
Beverly Hills, California, United States, 90211 | |
United States, Colorado | |
Univ of Colorado / Health Science Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Rhode Island | |
Brown Univ School of Medicine | |
Providence, Rhode Island, United States, 02908 | |
United States, Virginia | |
Hampton Roads Med Specialists | |
Hampton, Virginia, United States, 23666 |
Study ID Numbers: | 259G, ICC 602 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002235 |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination HIV Protease Inhibitors Indinavir Nelfinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents efavirenz |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Indinavir HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Nelfinavir Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |