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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00004855 |
This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease inhibitors are all types of anti-HIV drugs that block the virus in some way. This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection. This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients.
Condition | Intervention |
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HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Abacavir sulfate Drug: Nevirapine Drug: Lamivudine Drug: Stavudine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized, Open-Label, Pilot Treatment Trial Evaluating Cellular Dynamics and Immune Restoration in Treatment-Naive HIV-Infected Subjects Receiving Either the Protease Inhibitor LPV/r or the Nucleoside Analogue Reverse Transcriptase Inhibitors d4T/3TC/Abacavir With the Non-Nucleoside Reverse Transcriptase Inhibitor Nevirapine |
Estimated Enrollment: | 50 |
This study is designed to further define the dynamics and the mechanisms of the CD4 cell rise seen following administration of potent antiretroviral therapy. It will ascertain if treatment regimens containing nucleoside reverse transcriptase inhibitors (NRTIs) with a nonnucleoside reverse transcriptase inhibitor (NNRTI) have different effects on CD4 dynamics than regimens composed of a protease inhibitor with an NNRTI.
Patients are randomized to one of the two treatment arms listed below. They are stratified based on CD4 count and whether they choose to participate in substudy A5036s. Arm A (protease inhibitor plus NNRTI regimen): At Day 0 (entry), patients begin taking LPV/RTV. At Day 3, patients add NVP, once daily for 2 weeks and then twice daily for the remainder of the study. Arm B (triple reverse transcriptase inhibitors plus NNRTI regimen): At Day 0 (entry), patients begin taking 3TC plus d4T plus ABC. At Day 3, patients add NVP, once daily for 2 weeks and then twice daily for the remainder of the study.
HIV RNA analysis is performed at Weeks 4 and 5. If the mean is at least 1.0 log10 lower than the baseline HIV RNA, the patient may continue on study treatment. If the mean is not at least 1.0 log10 lower, however, patients are discontinued from the study by no later than Week 8. After 8 weeks of treatment, patients may change antiretroviral medications with permission of the protocol chair or vice chairs. Regular clinical evaluations are conducted. Blood is drawn to determine HIV RNA quantification, absolute CD4 and CD8 counts, immunological evaluations, telomere assays, and part is stored for future testing. Skin testing and return visits for delayed-type hypersensitivity to standard recall antigens are done on three occasions.
Patients remain on the study for 48 weeks. Substudy A5036s evaluates viral dynamics during study treatment. Serial plasma samples are collected during the first 24 hours of treatment and at Day 3 and Week 4. Plasma HIV measurements are performed to differentiate between infectious and non-infectious particle production.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
Denver Dept of Health and Hosps | |
Denver, Colorado, United States, 80262 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
Methodist Hosp of Indiana / Life Care Clinic | |
Indianapolis, Indiana, United States, 46202 | |
Division of Inf Diseases/ Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 441091998 | |
United States, Rhode Island | |
Miriam Hosp / Brown Univ | |
Providence, Rhode Island, United States, 02906 | |
United States, Texas | |
Univ of Texas Galveston | |
Galveston, Texas, United States, 775550435 |
Study Chair: | Alan Landay | |
Study Chair: | Michael Lederman |
Study ID Numbers: | ACTG A5014, substudy ACTG AA5036s, AACTG A5014 |
Study First Received: | February 29, 2000 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00004855 History of Changes |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Nevirapine Stavudine HIV Protease Inhibitors Ritonavir |
Lamivudine Reverse Transcriptase Inhibitors Anti-HIV Agents ABT 378 abacavir |
Antimetabolites HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors |
Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Anti-Retroviral Agents Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Abacavir Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Nevirapine HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |