NCT00067782

Brief Summary

The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

April 14, 2011

Status Verified

January 1, 2010

Enrollment Period

2.2 years

First QC Date

August 27, 2003

Last Update Submit

April 7, 2011

Conditions

HIV Infections

Keywords

HIVTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Time to virologic rebound for subjects with HIV RNA < 50 c/mL at baseline; Magnitude/ durability of increases from baseline in absolute CD4 (Time-Averaged Difference) through WK12; Mean % change from baseline in fasting LDL cholesterol at WK12.

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Atazanavir (immediate switch)

2

ACTIVE COMPARATOR
Drug: Atazanavir (Week 24 switch)

Interventions

Atazanavir (immediate switch)DRUG

Capsules, Oral, 400mg, Once daily, 48 weeks.

Also known as: Reyataz
1
Atazanavir (Week 24 switch)DRUG

Capsules, Oral, 400mg, Once daily, 48 weeks.

Also known as: Reyataz
2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first PI ever received
  • Plasma HIV-1 RNA level \< 50 c/mL within 3 to 6 months prior to study start
  • Fasting LDL cholesterol \> 130 mg/dL

You may not qualify if:

  • WOCBP who do not use effective barrier contraception for any reason
  • Women who are pregnant or breast feeding
  • A life expectancy \< 12 months
  • Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
  • Cushing's Syndrome
  • Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome
  • Untreated hypothyroidism or hyperthyroidism
  • Nephrotic syndrome or significant proteinuria
  • Obstructive liver disease
  • Active alcohol or substance abuse
  • Proven or suspected acute hepatitis in the 30 days prior to study entry
  • Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start
  • History of acute or chronic pancreatitis
  • Inability to swallow capsules
  • Presence of cardiomyopathy
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Local Institution

Phoenix, Arizona, United States

Location

Local Institution

West Hollywood, California, United States

Location

Local Institution

Washington D.C., District of Columbia, United States

Location

Local Institution

Altamonte Springs, Florida, United States

Location

Local Institution

Fort Lauderdale, Florida, United States

Location

Local Institution

Miami, Florida, United States

Location

Local Institution

Tampa, Florida, United States

Location

Local Institution

Boston, Massachusetts, United States

Location

Local Institution

Minneapolis, Minnesota, United States

Location

Local Institution

St Louis, Missouri, United States

Location

Local Institution

East Orange, New Jersey, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Huntersville, North Carolina, United States

Location

Local Institution

Cleveland, Ohio, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Philadelphia, Pennsylvania, United States

Location

Local Institution

Columbia, South Carolina, United States

Location

Local Institution

Fort Worth, Texas, United States

Location

Local Institution

Houston, Texas, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 27, 2003

First Posted

August 28, 2003

Study Start

December 1, 2002

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

April 14, 2011

Record last verified: 2010-01

Locations

US(19)