- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386659
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.
October 10, 2006 updated by: Hospital Clinic of Barcelona
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08025
- Hospital de Sant Pau
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Barcelona, Spain, 08035
- Hospital Vall d'Hebron
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Barcelona, Spain, 08036
- Hospital Clinic
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08907
- CSU Bellvitge
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
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Secondary Outcome Measures
Outcome Measure |
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Mortality
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Degree and kinetics of recovery of the immune system.
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New CDC C events
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Josep M Gatell, MD, Hospital Clinic of Barcelona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 11, 2006
Study Record Updates
Last Update Posted (Estimate)
October 11, 2006
Last Update Submitted That Met QC Criteria
October 10, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Tenofovir
- Ritonavir
- Lopinavir
- Efavirenz
- Abacavir
- Dideoxynucleosides
Other Study ID Numbers
- ADVAN-Z-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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