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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
  Purpose

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.


Condition Intervention Phase
HIV Infection
 Drug: tenofovir + abacavir + lopinavir/ritonavir
Drug: tenofovir + abacavir + efavirenz
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

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

Estimated Enrollment: 60
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386659

Locations
Spain
CSU Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic
Barcelona, Spain, 08036
Hospital de Sant Pau
Barcelona, Spain, 08025
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Study Chair: Josep M Gatell, MD Hospital Clinic de Barcelona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00386659     History of Changes
Other Study ID Numbers: ADVAN-Z-2
Study First Received: October 10, 2006
Last Updated: October 10, 2006
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
 Efavirenz
Abacavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013