NCT00775606|TerminatedPhase 4Results
Study Stopped
Study stopped 12/2010 due to poor enrollment. Only 15 of 60 needed enrolled.
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Study stopped 12/2010 due to poor enrollment. Only 15 of 60 needed enrolled.
A Phase 4 Study of the Effect on Immune Reconstitution of a Lopinavir/Ritonavir-Based Versus an Efavirenz-based HAART (Highly Active Antiretroviral Therapy) Regimen in Antiretroviral-Naïve Subjects With Advanced HIV Disease
Sponsor study identifier
interventional
15
1 country
4
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
January 2011
Actual (reported)The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function better than regimens that do not contain protease inhibitors. This is a study that will determine the difference in immune enhancement capabilities between an anti-HIV regimen that contains the protease inhibitor - lopinavir-ritonavir, and a regimen that contains efavirenz. Both medications are recommended as first line treatments for HIV-infected patients. This study will recruit HIV-positive patients that need to start anti-HIV treatment because their CD4+ T-cells are below 200. The usual threshold for starting treatment is a CD4+ T-cell less than 350. Subjects will be randomized to treatment with either an anti-HIV regimen that contains lopinavir-ritonavir or a regimen that contains efavirenz. The study will determine the difference in immune reconstitution over 24 weeks of treatment with study medications. Among the immune parameters that will be measured is the ability of each subject to respond to vaccination with the tetanus-diphtheria vaccine and the 23-valent pneumococcal vaccine. Both vaccines are also recommended for HIV-positive patients but HIV-positive patients tend to have a lower response rate to these vaccines.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 17, 2008
Actual (reported)October 20, 2008
Actual (reported)December 2010
Actual (reported)January 2011
Actual (reported)May 29, 2014
Actual (reported)CD4+ (Cluster of Differentiation 4) T-cell Apoptosis
Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.
24 weeks from treatment initiation (baseline and week 24)
CD4+ T-cell Change
24 weeks after treatment initiation (baseline and week 24)
Naive, Central Memory, Effector Memory, and T Reg CD4+ T-cell Frequency
baseline measurements
Naive, Central Memory, Effector Memory, and T Reg CD4+ T-cell Frequency
week 24 measurements
Activation and Proliferation of CD4+ and CD8+ T-cell Frequencies
baseline measurements
Activated and Regulatory CD4+ and CD8+ T-cell Frequencies
week 24 measurements
Subjects randomized to Arm A initiated Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
Subjects randomized to Arm B initiated Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Lopinavir 400 mg/ritonavir 100 mg fixed dose combination BID + emtricitabine 200 mg/tenofovir 300 mg fixed dose combination QD
Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg fixed dose combination QD
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lopinavir 400 mg/ritonavir 100 mg
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordRush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Pitrak DL, Novak RM, Estes R, Tschampa J, Abaya CD, Martinson J, Bradley K, Tenorio AR, Landay AL. Short communication: Apoptosis pathways in HIV-1-infected patients before and after highly active antiretroviral therapy: relevance to immune recovery. AIDS Res Hum Retroviruses. 2015 Feb;31(2):208-16. doi: 10.1089/aid.2014.0038. Epub 2014 Nov 11.
Study was terminated due to the slow recruitment and the small number of subjects.
Allan R. Tenorio, M.D.
Rush University Medical Center
15 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2008
First Posted
October 20, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetic Study of Interaction Between Nevirapine and Methadone in HIV-1 Infected, Opioid-dependent Adults
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
May 26, 2023
Results First Posted
May 29, 2014
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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