Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
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
5 other identifiers
interventional
55
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedNovember 1, 2021
October 1, 2021
February 29, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- 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.
You may not qualify if:
- Patients will not be eligible for this study if they:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Related Publications (1)
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.
PMID: 24326304DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alan Landay
- STUDY CHAIR
Michael Lederman
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2000
First Posted
August 31, 2001
Study Completion
April 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10