Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207142
First received: September 16, 2005
Last updated: January 7, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.


Condition Intervention Phase
HIV Infections
Drug: Atazanavir + 2 NRTIs
Drug: Atazanavir + Ritonavir + 2 NRTIs
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase [ Time Frame: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase [ Time Frame: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase ] [ Designated as safety issue: No ]
  • Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase [ Time Frame: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48 ] [ Designated as safety issue: No ]
  • Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase [ Time Frame: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48 ] [ Designated as safety issue: No ]
  • Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase [ Time Frame: End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase [ Time Frame: Baseline, Week 24 of Induction Phase ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase [ Time Frame: Baseline, Week 48 of Rescue Phase ] [ Designated as safety issue: No ]
  • Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase [ Time Frame: Baseline, Week 24 of Induction Phase ] [ Designated as safety issue: No ]
  • Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase [ Time Frame: \Baseline, Week 48 of Rescue Phase ] [ Designated as safety issue: No ]
  • Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase [ Time Frame: Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days. ] [ Designated as safety issue: No ]
  • Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase [ Time Frame: Baseline, Week 48 of Rescue Phase ] [ Designated as safety issue: No ]
  • Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase [ Time Frame: Week 16-18, Week 24-26, Week 38-40, Week 64-66 ] [ Designated as safety issue: No ]
  • Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase [ Time Frame: Week 16-18, Week 24-26, Week 30-32 ] [ Designated as safety issue: No ]
  • Summary of Adverse Events During Induction Phase [ Time Frame: Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days). ] [ Designated as safety issue: Yes ]
  • Summary of Adverse Events During Maintenance Phase [ Time Frame: Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days. ] [ Designated as safety issue: Yes ]
  • Summary of Adverse Events During Rescue Phase [ Time Frame: Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days. ] [ Designated as safety issue: Yes ]
  • Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase [ Time Frame: Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase. ] [ Designated as safety issue: Yes ]

Enrollment: 252
Study Start Date: November 2005
Study Completion Date: January 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Switch
ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)
Drug: Atazanavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Other Name: Reyataz
Active Comparator: Continuation
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
Drug: Atazanavir + Ritonavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Other Name: Reyataz
Rescue
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
Drug: Atazanavir + Ritonavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Other Name: Reyataz

  Eligibility

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

Inclusion Criteria:

  • Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).
  • Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
  • Subjects who have a CD4 count ≥ 50 cells/mm3.
  • Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
  • Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
  • WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
  • Primary HIV infection
  • Medical History and Concurrent Diseases
  • Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
  • Screening laboratory values measured as follows:
  • Grade IV glucose,
  • Grade IV electrolytes,
  • Grade IV transaminases,
  • Grade IV hematology.
  • Hypersensitivity to any component of the formulation of study drug
  • Prior history of taking any ARV for more than 10 days
  • Concomitant administration of tenofovir (TDF).
  • Refer to Section 6.4.1 which details all prohibited therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207142

Locations
Estonia
Local Institution
Tallinn, Estonia
France
Local Institution
Le Kremlin Bicetre 94, France
Local Institution
Orleans, France
Local Institution
Paris, France
Local Institution
Paris Cedex 12, France
Local Institution
Paris Cedex 20, France
Local Institution
Suresnes, France
Germany
Local Institution
Dusseldorf, Germany
Local Institution
Hannover, Germany
Local Institution
Stuttgart, Germany
Local Institution
Ulm, Germany
Ireland
Local Institution
Dublin 3, Dublin, Ireland
Local Institution
Dublin 8, Dublin, Ireland
Italy
Local Institution
Brescia, Italy
Local Institution
Milano, Italy
Local Institution
Napoli, Italy
Local Institution
Padova, Italy
Latvia
Local Institution
Riga, Latvia
Portugal
Local Institution
Cascais, Portugal
Local Institution
Porto, Portugal
Russian Federation
Local Institution
Moscow, Russian Federation
Local Institution
Smolensk, Russian Federation
Local Institution
St. Petersburg, Russian Federation
Spain
Local Institution
Elche, Alicante, Spain
Local Institution
Barcelona, Spain
Local Institution
Madrid, Spain
Local Institution
Valencia, Spain
United Kingdom
Local Institution
Bristol, Avon, United Kingdom
Local Institution
Edinburgh, Central, United Kingdom
Local Institution
London, Greater London, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00207142     History of Changes
Other Study ID Numbers: AI424-136
Study First Received: September 16, 2005
Results First Received: June 2, 2009
Last Updated: January 7, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bristol-Myers Squibb:
Treatment Naive
HIV-1 infected treatment naive patients

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014