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

Phase 4

Terminated

• Conditions: HIV Infection

• Registration Number: NCT00386659
• Lead Sponsor: Hospital Clinic of Barcelona

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 available

Study Timeline

• Status Verified: 2006-10
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Last Update Submitted: 2006-10-10
• Study First Posted: 2006-10-11
• Last Update Posted: 2006-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

CSU Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain