NCT00337467

Brief Summary

The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

7 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

June 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 19, 2010

Completed
Last Updated

July 19, 2010

Status Verified

June 1, 2010

Enrollment Period

1.9 years

First QC Date

June 14, 2006

Results QC Date

May 21, 2010

Last Update Submit

June 18, 2010

Conditions

Human Immunodeficiency Virus (HIV) Infections

Keywords

HIV-Infected Patients Evidencing Virologic Suppression

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Treatment Failure Through Week 48

    Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy.

    Week 48

Secondary Outcomes (13)

  • Percentage of Participants With Treatment Failure Through Week 96

    Week 96

  • Percentage of Participants With Virological Rebound Through Week 48

    Week 48

  • Percentage of Participants With Virological Rebound Through Week 96

    Week 96

  • Cumulative Proportion of Participants Without Treatment Failure Through Week 100

    Through Week 100

  • Proportion of Participants With Virologic Rebound Through Week 96

    Through Week 96

  • +8 more secondary outcomes

Study Arms (1)

A1

EXPERIMENTAL
Drug: Atazanavir + Ritonavir

Interventions

Atazanavir + RitonavirDRUG

Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks

Also known as: Reyataz, BMS-232632
A1

Eligibility Criteria

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

You may qualify if:

  • On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks).
  • Absence of evidence or suspected virologic failure on antiretroviral therapy
  • Absence of known primary mutations in the protease gene
  • Only 1 highly active antiretroviral therapy (HAART) prior to current one
  • HIV RNA \< 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)
  • On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir \[TDF\]) for at least 8 weeks before study entry, without treatment-limiting adverse effects

You may not qualify if:

  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
  • Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease)
  • Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC).
  • CD4 \< 100 cells/mm3
  • Grade IV laboratory values: Hemoglobin \< 6.5 g/dL or white blood cells (WBC) \<800/mmm3 or absolute neutrophil count \< 500/mm3, or platelets \< 20,000/mm3 or diffuse petechiae.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Local Institution

Córdoba, 14004, Spain

Location

Local Institution

Madrid, 28007, Spain

Location

Local Institution

Madrid, 28034, Spain

Location

Local Institution

Madrid, 28040, Spain

Location

Local Institution

Madrid, 28041, Spain

Location

Local Institution

Madrid, 28046, Spain

Location

Local Institution

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeInfections

Interventions

atazanavir, ritonavir drug combinationAtazanavir Sulfate

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
BMS Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2009

Last Updated

July 19, 2010

Results First Posted

July 19, 2010

Record last verified: 2010-06

Locations

ES(7)