A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-Based HAART Regimens in HIV-Infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-Containing HAART Regimen - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135395

Purpose

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanavir+ritonavir Drug: Lopinavir+ritonavir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir Atazanavir sulfate BMS 232632 Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIb, Open -Label, Randomized Multi-Center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-Containing HAART Regimen.

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12

Secondary Outcome Measures:

Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.

Estimated Enrollment:	200
Study Start Date:	May 2004

Arms	Assigned Interventions
A: Active Comparator	Drug: Atazanavir+ritonavir Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
B: Active Comparator	Drug: Lopinavir+ritonavir Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Patients ≥ 18 years of age infected with HIV
Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)

Exclusion Criteria:

Pregnancy or breastfeeding
Reported virologic failure to two or more antiretroviral regimens
Active AIDS-defined opportunistic infection or disease
Proven or suspected acute hepatitis within 30 days prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135395

Show 53 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	AI424-103
Study First Received:	August 25, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00135395
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV/AIDS
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009