NCT00775606

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

Terminated Phase 4 Results posted Last updated 2 May 2023

What this trial tests

Phase 4 trial testing Lopinavir 400 mg/ritonavir 100 mg in Acquired Immune Deficiency Syndrome in 15 participants. Terminated before completion.

Timeline

1 October 2008

Primary endpoint
1 December 2010

1 January 2011

Quick facts

Lead sponsor	Rush University Medical Center
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 October 2008
Primary completion	1 December 2010
Estimated completion	1 January 2011
Sites	4 locations across United States

Drugs / interventions tested

• Lopinavir 400 mg/ritonavir 100 mg — full drug profile →
• Efavirenz (EFAVIRENZ) — full drug profile →

Conditions studied

• Acquired Immune Deficiency Syndrome — all drugs for Acquired Immune Deficiency Syndrome →

Sponsor

Rush University Medical Center

Who can join

Adults 18 to 60, any sex, with Acquired Immune Deficiency Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• CD4+ (Cluster of Differentiation 4) T-cell Apoptosis
  Time frame: 24 weeks from treatment initiation (baseline and week 24)
  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 ap

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Short communication: Apoptosis pathways in HIV-1-infected patients before and after highly active antiretroviral therapy: relevance to immune recovery.
   Pitrak DL, Novak RM, Estes R, Tschampa J, et al · · 2015 · cited 8× · PMID 25386736 · DOI 10.1089/aid.2014.0038