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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00386659
• Date of registration: 10/10/2006
• Prospective Registration: No
• Primary sponsor: Hospital Clinic of Barcelona
• Public title: Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.
• Scientific title: 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
• Date of first enrolment: February 2004
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00386659
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Spain

Contacts

• Name: Josep M Gatell, MD
• Affiliation: Hospital Clinic de Barcelona

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: tenofovir + abacavir + efavirenz

Drug: tenofovir + abacavir + lopinavir/ritonavir

Primary Outcome(s)

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

Secondary Outcome(s)

New CDC C events

Degree and kinetics of recovery of the immune system.

Mortality

Secondary ID(s)

ADVAN-Z-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors