Once-Daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl - Full Text View

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00532168

Purpose

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3.

Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

Design:

Condition	Intervention	Phase
HIV Infections	Drug: tenofovir + emtricitabine + efavirenz Drug: tenofovir + emtricitabine + lopinavir-ritonavir Drug: tenofovir + emtricitabine + atazanavir-ritonavir	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Efavirenz Ritonavir Lopinavir BMS 232632 Tenofovir disoproxil Tenofovir Disoproxil Fumarate Atazanavir sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Once-Daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental tenofovir plus emtricitabine plus efavirenz	Drug: tenofovir + emtricitabine + efavirenz tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
2: Experimental tenofovir plus emtricitabine plus lopinavir-ritonavir	Drug: tenofovir + emtricitabine + lopinavir-ritonavir tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
3: Experimental tenofovir plus emtricitabine plus atazanavir-ritonavir	Drug: tenofovir + emtricitabine + atazanavir-ritonavir tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD

Eligibility

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

Criteria

Inclusion Criteria:

Chronic HIV-1 infection
Age 18 or more
Antiretroviral-naive
Baseline CD4+ count <100 cels/mcL.
No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
Written informed consent

Exclusion Criteria:

Hypersensibility to study drugs.
Pregnancy or breastfeeding
Active OI requiring admission
Active lymphoma or malignancy (Kaposi sarcoma included)
Cl creatinine below 30 ml/min.
Liver failure
Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532168

Contacts

Contact: Jose M Miró, MD

oo34932275430

jmmiro@clinic.ub.es

Locations

Spain, Catalonia
Hospital Clinic	Recruiting
Barcelona, Catalonia, Spain, 08036
Principal Investigator: Jose M Miró, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Study Chair:

Jose M Miró, MD

Hospital Clinic Barcelona

More Information

No publications provided

Responsible Party:	Hospital Clinic, Barcelona ( Josep M Miró )
Study ID Numbers:	ADVANZ-3, EudraCT: 2006-006268-42, FIS grant: EC07/90642
Study First Received:	September 18, 2007
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00532168 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

advanced HIV-infected patients
late presenters
antiretroviral therapy
immune reconstitution
Treatment Naive

Study placed in the following topic categories:

Efavirenz
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors

Virus Diseases
Anti-Retroviral Agents
Emtricitabine
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Lopinavir
Emtricitabine
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
Efavirenz

RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Ritonavir
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 07, 2009