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NCT00386659 Clinical Trial

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

HIV Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00386659
Other study ID # ADVAN-Z-2
Secondary ID
Status Terminated
Phase Phase 4
First received October 10, 2006
Last updated October 10, 2006

Study information
Verified date October 2006
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tenofovir + abacavir + lopinavir/ritonavir

• tenofovir + abacavir + efavirenz

Locations
Country Name City State
Spain Hospital Clinic Barcelona
Spain Hospital de Sant Pau Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain CSU Bellvitge Hospitalet de Llobregat Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
Secondary Degree and kinetics of recovery of the immune system.
Secondary New CDC C events
Secondary Mortality
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