NCT00120393

Brief Summary

Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
2 countries

14 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

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 5, 2010

Status Verified

July 1, 2009

Enrollment Period

2.3 years

First QC Date

July 12, 2005

Last Update Submit

February 3, 2010

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.

Secondary Outcomes (7)

  • Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.

  • Mean change in cholesterol measures at Weeks 12, 24 and 48.

  • Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.

  • The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.

  • The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.

  • +2 more secondary outcomes

Study Arms (2)

G1

ACTIVE COMPARATOR
Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)

G2

ACTIVE COMPARATOR
Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)

Interventions

atazanavir/ritonavir +2 NRTIs (immediate Switch Group)DRUG

Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.

Also known as: Reyataz
G1
LPV/r +2 NRTIs (Delayed/optional Switch Group)DRUG

Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.

G2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • LPV/RTV-based HAART for at least 6 months
  • HIV-1 RNA less than 50c/mL (confirmed)
  • Non-HDL higher than 160 mg/dL
  • CD4 of at least 50 cells/mL

You may not qualify if:

  • Use of lipid-lowering agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Local Institution

Phoenix, Arizona, United States

Location

Local Institution

Bakersfield, California, United States

Location

Local Institution

Los Angeles, California, United States

Location

Local Institution

San Francisco, California, United States

Location

Local Institution

Miami, Florida, United States

Location

Local Institution

Boston, Massachusetts, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Cincinnati, Ohio, United States

Location

Local Institution

Portland, Oregon, United States

Location

Local Institution

Philadelphia, Pennsylvania, United States

Location

Local Institution

Columbia, South Carolina, United States

Location

Local Institution

Dallas, Texas, United States

Location

Local Institution

Hamilton, Ontario, Canada

Location

Local Institution

Montreal, Quebec, Canada

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
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 18, 2005

Study Start

January 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 5, 2010

Record last verified: 2009-07

Locations

US(12)CA(2)