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
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 Arms

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

Sex/Gender

Sexes Eligible for Study:

All

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

PRS Account

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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