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

NCT00207142 | Completed Phase 4 Results

• 1 other identifier: AI424-136
• Study Type: interventional
• Target: 252
• Locations: 9 countries
• Sites: 26

Brief Summary

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.

Conditions

HIV Infections

Keywords

Treatment Naive; HIV-1 infected treatment naive patients

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase

  Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.

  From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase

Secondary Outcomes (16)

• Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase

  From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase

• Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase

  Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48

• Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase

  Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48

• Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase

  End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase

• Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase

  Baseline, Week 24 of Induction Phase

Study Arms (3)

Switch

ACTIVE COMPARATOR

ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)

Drug: Atazanavir + 2 NRTIs

Continuation

ACTIVE COMPARATOR

ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)

Drug: Atazanavir + Ritonavir + 2 NRTIs

Rescue

OTHER

ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)

Drug: Atazanavir + Ritonavir + 2 NRTIs

Interventions

Atazanavir + 2 NRTIs DRUG

Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

Also known as: Reyataz

Switch

Atazanavir + Ritonavir + 2 NRTIs DRUG

Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

Also known as: Reyataz

Continuation; Rescue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (27)

Local Institution

Tallinn, Estonia

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Le Kremlin-Bicêtre, France

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Orléans, France

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Paris, France

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Suresnes, France

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Düsseldorf, Germany

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Hanover, Germany

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Stuttgart, Germany

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Ulm, Germany

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Dublin, Dublin, Ireland

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Brescia, Italy

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Milan, Italy

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Napoli, Italy

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Padua, Italy

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Riga, Latvia

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Cascais, Portugal

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Porto, Portugal

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Moscow, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Elche, Alicante, Spain

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Barcelona, Spain

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Madrid, Spain

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Valencia, Spain

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Bristol, Avon, United Kingdom

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Edinburgh, Central, United Kingdom

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London, Greater London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Results Point of Contact

• Title: 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: January 1, 2008
• Last Updated: January 12, 2010
• Results First Posted: January 7, 2010

Record last verified: 2010-01

Locations

IE (1); LA (1); PT (2); RU (3); DE (4); IT (4); GB (3); FR (4); ES (4)