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

Tracking Information

First Received Date ^ICMJE

October 10, 2006

Last Updated Date

October 10, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Degree and kinetics of recovery of the immune system.
New CDC C events
Mortality

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: tenofovir + abacavir + lopinavir/ritonavir
Drug: tenofovir + abacavir + efavirenz

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00386659

Other Study ID Numbers ^ICMJE

ADVAN-Z-2

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Josep M Gatell, MD

Hospital Clinic of Barcelona

Information Provided By

Hospital Clinic of Barcelona

Verification Date

October 2006

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

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