Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100

HIV Infections Clinical Trial

Official title:

Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385957
• Other study ID #: ADVAN-Z
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: December 14, 2010

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

The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed HIV-1 infection.

• Age 18 years or over.

• No previous antiretroviral therapy.

• CD4 lymphocyte count of < 100 cells/mL.

• Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.

Exclusion Criteria:

• Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.

• Currently undergoing treatment for an opportunistic infection (parenteral administration).

• Any formal contraindication to treatment with 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

• HIV Infections

Intervention

Drug:
• AZT+3TC+IDV+RTV

• AZT+3TC+EFV

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	CSU Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Donostia Ospitaleak	San Sebastian	Giputzkoa

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 VL below 20 copies/ml in plasma at 12 and 24 months.
Primary	Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
Secondary	Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
Secondary	CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
Secondary	and levels of CD8 cells (CD28+ y CD38+)
Secondary	Incidence of adverse events