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

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 4


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators


Study Chair:	Jose M Gatell, MD	Hospital Clinic of Barcelona

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Miró JM, Manzardo C, Pich J, Domingo P, Ferrer E, Arribas JR, Ribera E, Arrizabalaga J, Loncá M, Cruceta A, de Lazzari E, Fuster M, Podzamczer D, Plana M, Gatell JM; Advanz Study Group. Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Res Hum Retroviruses. 2010 Jul;26(7):747-57. doi: 10.1089/aid.2009.0105.


ClinicalTrials.gov Identifier:	NCT00385957 History of Changes
Other Study ID Numbers:	ADVAN-Z
Study First Received:	October 10, 2006
Last Updated:	December 14, 2010
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:


Treatment Naive

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2016