Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

This study has been terminated.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00386659
First received: October 10, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 10, 2006
October 10, 2006
Not Provided
Not Provided
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
Same as current
No Changes Posted
  • Degree and kinetics of recovery of the immune system.
  • New CDC C events
  • Mortality
Same as current
Not Provided
Not Provided
 
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.
A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: tenofovir + abacavir + lopinavir/ritonavir
  • Drug: tenofovir + abacavir + efavirenz
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
Not Provided
Not Provided

Inclusion Criteria:

  • HIV-infection
  • Antiretroviral-naive
  • CD4 cell count below 100 cells/mm3

Exclusion Criteria:

  • Pregnancy
  • Current opportunistic infection requiring parenteral therapy
  • Current malignancies requiring parenteral chemotherapy
  • Any contraindication to the study drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00386659
ADVAN-Z-2
Not Provided
Not Provided
Hospital Clinic of Barcelona
Not Provided
Study Chair: Josep M Gatell, MD Hospital Clinic de Barcelona
Hospital Clinic of Barcelona
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP