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

Primary Purpose

HIV Infection

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
tenofovir + abacavir + lopinavir/ritonavir
tenofovir + abacavir + efavirenz
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CSU Bellvitge
  • Hospital de Sant Pau
  • Hospital Vall d'Hebron
  • Hospital Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2006
Last Updated
October 10, 2006
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00386659
Brief Title
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tenofovir + abacavir + lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
tenofovir + abacavir + efavirenz
Primary Outcome Measure Information:
Title
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
Secondary Outcome Measure Information:
Title
Degree and kinetics of recovery of the immune system.
Title
New CDC C events
Title
Mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep M Gatell, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
Facility Information:
Facility Name
CSU Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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