Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
NCT ID: NCT00004855
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2005-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Lopinavir/Ritonavir
Abacavir sulfate
Nevirapine
Lamivudine
Stavudine
Eligibility Criteria
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Inclusion Criteria
* Are 18 years of age or older.
* Are HIV-positive.
* Have a CD4 count of 500 cells/mm3 or less.
* Have a viral load greater than 5,000 and less than 100,000 copies/ml.
* Are willing to use barrier methods of birth control (such as condoms) during the study and for 12 weeks after stopping treatment.
* Will most likely respond well to nevirapine. This is determined by the results of a test.
Exclusion Criteria
* Have ever taken any anti-HIV drugs. (Seven days or less of treatment will be allowed if it was received more than 30 days before study entry.)
* Have pancreatitis (an inflamed pancreas) or hepatitis within 2 weeks of study entry.
* Are pregnant or breast-feeding.
* Actively abuse drugs or alcohol which their doctor feels would interfere with the ability to fulfill study requirements.
* Have taken any medications within 14 days of study entry that would interfere with the study drugs.
* Are receiving or need to receive chemotherapy.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Alan Landay
Role: STUDY_CHAIR
Michael Lederman
Role: STUDY_CHAIR
Locations
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Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Denver Dept of Health and Hosps
Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Med Ctr
Cleveland, Ohio, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States
Univ of Texas Galveston
Galveston, Texas, United States
Countries
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References
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Lok JJ, Hunt PW, Collier AC, Benson CA, Witt MD, Luque AE, Deeks SG, Bosch RJ. The impact of age on the prognostic capacity of CD8+ T-cell activation during suppressive antiretroviral therapy. AIDS. 2013 Aug 24;27(13):2101-10. doi: 10.1097/QAD.0b013e32836191b1.
Other Identifiers
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10866
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5014
Identifier Type: -
Identifier Source: secondary_id
AACTG A5014
Identifier Type: -
Identifier Source: secondary_id
Substudy ACTG AA5036s
Identifier Type: -
Identifier Source: secondary_id
A5014
Identifier Type: -
Identifier Source: org_study_id