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

Hospital Clinic of Barcelona

Status and phase: Terminated; Phase 4

Conditions: HIV Infection

Treatments: Drug: tenofovir + abacavir + lopinavir/ritonavir; Drug: tenofovir + abacavir + efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT00386659

ADVAN-Z-2

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)