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Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100

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ClinicalTrials.gov Identifier: NCT00385957
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:
Hospital Clinic of Barcelona

Study Description
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Brief Summary:
The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: AZT+3TC+IDV+RTV Drug: AZT+3TC+EFV Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
  2. Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.

Secondary Outcome Measures :
  1. Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
  2. CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
  3. and levels of CD8 cells (CD28+ y CD38+)
  4. Incidence of adverse events

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed HIV-1 infection.
  • Age 18 years or over.
  • No previous antiretroviral therapy.
  • CD4 lymphocyte count of < 100 cells/mL.
  • Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.

Exclusion Criteria:

  • Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
  • Currently undergoing treatment for an opportunistic infection (parenteral administration).
  • Any formal contraindication to treatment with the study drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385957


Locations
Spain
CSU Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Donostia Ospitaleak
San Sebastian, Giputzkoa, Spain, 20014
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic
Barcelona, Spain, 08036
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Study Chair: Jose M Gatell, MD Hospital Clinic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00385957     History of Changes
Other Study ID Numbers: ADVAN-Z
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: October 2006

Keywords provided by Hospital Clinic of Barcelona:
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents