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

Phase 4TerminatedNCT00386659

Hospital Clinic of Barcelona60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection

Interventions

tenofovir + abacavir + lopinavir/ritonavirDRUG

tenofovir + abacavir + efavirenzDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Hospital de Sant Pau

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Clinic

Barcelona, Barcelona, Spain

CSU Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

Degree and kinetics of recovery of the immune system.

New CDC C events

Mortality

Data from ClinicalTrials.gov

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