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

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: AZT+3TC+EFV

Drug: AZT+3TC+IDV+RTV

Study type

Interventional

Funder types

Other

Identifiers

NCT00385957

ADVAN-Z

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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