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

Tracking Information
First Submitted Date ICMJE	October 10, 2006
First Posted Date ICMJE	October 11, 2006
Last Update Posted Date	October 11, 2006
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: October 10, 2006)	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; (submitted: October 10, 2006)	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: None (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; (submitted: October 10, 2006)	60
Original Enrollment ICMJE	Same as current
Study 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, Older Adult)
Accepts Healthy Volunteers	No
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