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
Results First Received: June 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Atazanavir + 2 NRTIs
Drug: Atazanavir + Ritonavir + 2 NRTIs

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
288 subjects were enrolled, of which 36 did not start Induction Phase Therapy (22 did not meet study criteria, 6 withdrew consent, 4 lost to follow-up, 3 had missing information, and 1 for investigator's decision).

Reporting Groups
  Description
Induction Treatment Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase
Maintenance Treatment: Switch Regimen Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI).
Maintenance Treatment: Continuation Regimen Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI).
Rescue Treatment Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).

Participant Flow for 2 periods

Period 1:   Induction Phase
    Induction Treatment     Maintenance Treatment: Switch Regimen     Maintenance Treatment: Continuation Regimen     Rescue Treatment  
STARTED     252     0     0     0  
COMPLETED     222 [1]   0     0     0  
NOT COMPLETED     30     0     0     0  
Adverse Event                 9                 0                 0                 0  
Death                 1                 0                 0                 0  
Lack of Efficacy                 1                 0                 0                 0  
Lost to Follow-up                 5                 0                 0                 0  
Physician Decision                 2                 0                 0                 0  
Poor/noncompliance                 2                 0                 0                 0  
Pregnancy                 1                 0                 0                 0  
Subject no longer meets study criteria                 3                 0                 0                 0  
Withdrawal by Subject                 4                 0                 0                 0  
Incarceration                 1                 0                 0                 0  
Missing lab data                 1                 0                 0                 0  
[1] Subjects randomized into Maintenance Phase=172 (87 ATV +85 ATV/RTV); Rescue Phase subjects=50

Period 2:   Maintenance Phase/Rescue Phase
    Induction Treatment     Maintenance Treatment: Switch Regimen     Maintenance Treatment: Continuation Regimen     Rescue Treatment  
STARTED     0     87     85     50  
COMPLETED     0     78     72     41  
NOT COMPLETED     0     9     13     9  
Adverse Event                 0                 1                 4                 1  
Lost to Follow-up                 0                 1                 1                 2  
RTV intake impossible                 0                 0                 1                 0  
Poor/noncompliance                 0                 3                 2                 3  
Pregnancy                 0                 2                 2                 0  
Subject no longer meets study criteria                 0                 0                 1                 0  
Withdrawal by Subject                 0                 2                 2                 1  
Death                 0                 0                 0                 1  
Lack of Efficacy                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Randomized Subjects: Switch Regimen ATV 400 mg QD + 2 NRTIs
Randomized Subjects: Continuation Regimen ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Nonrandomized Subjects All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
Total Total of all reporting groups

Baseline Measures
    Randomized Subjects: Switch Regimen     Randomized Subjects: Continuation Regimen     Nonrandomized Subjects     Total  
Number of Participants  
[units: participants]
  87     85     80     252  
Age, Customized  
[units: years]
Median ( Full Range )
  35  
  ( 21 to 66 )  
  35  
  ( 19 to 70 )  
  36  
  ( 20 to 71 )  
  36  
  ( 19 to 71 )  
Gender  
[units: participants]
       
Female     22     24     16     62  
Male     65     61     64     190  
Race/Ethnicity, Customized  
[units: Participants]
       
White     73     70     66     209  
Black     14     14     11     39  
Other     0     1     3     4  
Region of Enrollment  
[units: participants]
       
Europe     68     68     60     196  
Russian Federation     19     17     20     56  
Hepatitis B or C  
[units: Participants]
       
Hepatitis B/C positive     16     20     23     59  
Hepatitis B/C negative     71     65     57     193  
Baseline CD4  
[units: cells/mm3]
Median ( Full Range )
  255  
  ( 50 to 660 )  
  265  
  ( 64 to 490 )  
  227  
  ( 2 to 876 )  
  245  
  ( 2 to 876 )  
Baseline HIV-1 RNA  
[units: log10c/mL]
Median ( Full Range )
  4.85  
  ( 3.51 to 5.88 )  
  4.86  
  ( 3.58 to 5.88 )  
  5.46  
  ( 3.74 to 5.88 )  
  4.95  
  ( 3.51 to 5.88 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase   [ Time Frame: Baseline, Week 24 of Induction Phase ]

7.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase   [ Time Frame: Baseline, Week 48 of Rescue Phase ]

8.  Secondary:   Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase   [ Time Frame: Baseline, Week 24 of Induction Phase ]

9.  Secondary:   Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase   [ Time Frame: \Baseline, Week 48 of Rescue Phase ]

10.  Secondary:   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. ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase   [ Time Frame: Week 16-18, Week 24-26, Week 30-32 ]

14.  Secondary:   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). ]

15.  Secondary:   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. ]

16.  Secondary:   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. ]

17.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Bristol-Myers Squibb
e-mail: clinical.trials@bms.com


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)