Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patien... | NCT00028301

Studies
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

NCT00028301

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Sep 13, 2010Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

HIV Infections

Interventions

Atazanavir
Lopinavir/Ritonavir

Countries

United States
Argentina
Australia
Belgium
Brazil
Canada
Chile
France
Italy
Mexico
Netherlands
Peru
Puerto Rico
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
AI424-043

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2001

Primary Completion Date

Sep 2003Actual

Completion Date

Sep 2003Actual

First Submitted Date

Dec 20, 2001

First Submission Date that Met QC Criteria

Dec 20, 2001

First Posted Date

Dec 21, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 10, 2010

Certification/Extension First Submitted that Passed QC Review

Sep 10, 2010

Certification/Extension First Posted Date

Sep 13, 2010Estimated

Last Update Submitted Date

Sep 10, 2010

Last Update Posted Date

Sep 13, 2010Estimated

Description Module

Brief Summary

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

Detailed Description

The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.
Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.
Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.
Are at least 16 years old.
Have a documented virologic response to at least 1 HAART regimen.
Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.
Have phenotypic sensitivity to atazanavir and LPV/RTV.
Use effective barrier methods of birth control.
Will be available for 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have taken 2 or more PIs and had virologic failure.
Have taken atazanavir or LPV/RTV.
Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.
Have had acute hepatitis in the 30 days prior to study entry.
Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.
Abuse alcohol or drugs in a way that would interfere with the study.
Have very bad diarrhea within 30 days prior to study entry.
Are pregnant or breast-feeding.
Have a history of hemophilia.
Use lipid-lowering drugs (within the previous 30 days).
Have cardiomyopathy or symptoms of other heart disease.
Cannot take medicine by mouth.
Have any other condition that would interfere with the study.
Have pancreatitis, if choosing ddI as part of NRTI pair.
Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Atazanavir	Drug
Lopinavir/Ritonavir	Drug

Facility	Status	City	State	ZIP	Country	Contacts
Cooper Green Hosp		Birmingham	Alabama	35233	United States
Phoenix Body Positive

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000069446	Atazanavir Sulfate
D061466	Lopinavir

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011744	Pyrimidinones
D011743	Pyrimidines