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

September 16, 2005
January 7, 2010
November 2005
August 2007   (final data collection date for primary outcome measure)
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 ]
The primary endpoint measure will be the proportion of subjects with viral load < 50 c/mL through Week 48 of the Maintenance Phase between the 2 treatment arms.
Complete list of historical versions of study NCT00207142 on ClinicalTrials.gov Archive Site
  • 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 ]
The % of subjects with viral load <400 c/mL and time to treatment failure through Maintenance Phase; changes in CD4 and lipids, frequency and severity of adverse events (AEs), and discontinuations for AEs through Induction and Maintenance Phases.
Not Provided
Not Provided
 
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • 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
  • Active Comparator: Switch
    ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)
    Intervention: Drug: Atazanavir + 2 NRTIs
  • Active Comparator: Continuation
    ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
    Intervention: Drug: Atazanavir + Ritonavir + 2 NRTIs
  • Rescue
    ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
    Intervention: Drug: Atazanavir + Ritonavir + 2 NRTIs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
January 2008
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   France,   Germany,   Ireland,   Italy,   Latvia,   Portugal,   Russian Federation,   Spain,   United Kingdom
 
NCT00207142
AI424-136
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP