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| Sponsor: | Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002220 |
Purpose
The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Efavirenz Drug: Levocarnitine Drug: Adefovir dipivoxil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir |
| Estimated Enrollment: | 120 |
In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Nelfinavir-Failure Group:
Control Group:
Exclusion Criteria
Prior Medication:
Excluded:
Control group:
Required:
Nelfinavir-failure patients:
Control group:
Contacts and Locations| United States, California | |
| LAC / USC Med Ctr / Infectious Diseases | |
| Los Angeles, California, United States, 90033 | |
| United States, Connecticut | |
| Yale Univ / AIDS Clinical Trials Unit | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Delaware | |
| Med Ctr of Delaware | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Hawaii | |
| Hawaii AIDS Clinical Trial Unit | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Rush Presbyterian Saint Lukes Med Ctr | |
| Chicago, Illinois, United States, 606123832 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 212876220 | |
| United States, Massachusetts | |
| Massachusetts Gen Hosp | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| Columbia Presbyterian Hosp | |
| New York, New York, United States, 10032 | |
| AIDS TMT Unit / Univ Hosp | |
| Stonybrook, New York, United States, 117948153 | |
| United States, Tennessee | |
| Vanderbilt Clinic | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Oaklawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
More Information
| Study ID Numbers: | 246N, 075-00 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002220 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Resistance Drug Therapy, Combination Antiviral Agents HIV Protease Inhibitors |
Indinavir RNA, Viral Adenine efavirenz |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Indinavir Physiological Effects of Drugs Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Vitamins Micronutrients Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Vitamin B Complex Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections |