Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| 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:
- Serologically documented HIV infection.
- Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
- Parental consent for patients under 18.
Nelfinavir-Failure Group:
- Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
- Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
Control Group:
- Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
- Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.
Exclusion Criteria
Prior Medication:
Excluded:
Control group:
- Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
Required:
Nelfinavir-failure patients:
- At least 16 weeks of nelfinavir.
Control group:
- At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002220 History of Changes |
| Obsolete Identifiers: | NCT00002242 |
| Other Study ID Numbers: | 246N, 075-00 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Resistance Drug Therapy, Combination Antiviral Agents HIV Protease Inhibitors |
Indinavir RNA, Viral Adenine efavirenz |
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 Carnitine Adefovir Adefovir dipivoxil Indinavir |
Nelfinavir Efavirenz HIV Protease Inhibitors Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013