Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100 - Full Text View

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00385957

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Drug: AZT+3TC+IDV+RTV Drug: AZT+3TC+EFV	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.

Secondary Outcome Measures:

Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
and levels of CD8 cells (CD28+ y CD38+)
Incidence of adverse events

Estimated Enrollment:

70

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385957

Locations

Spain
Hospital Clinic
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Vall d’Hebron
Barcelona, Spain, 08035
Hospital Universitario La Paz
Madrid, Spain, 28046
Spain, Barcelona
CSU Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Spain, Giputzkoa
Donostia Ospitaleak
San Sebastian, Giputzkoa, Spain, 20014

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Study Chair:

Jose M Gatell, MD

Hospital Clinic de Barcelona

More Information

Study ID Numbers:	ADVAN-Z
Study First Received:	October 10, 2006
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00385957
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Lamivudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009