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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Lamivudine

Criteria

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