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Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01003990
First received: October 20, 2009
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: February 2, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Other
Condition: HIV
Interventions: Drug: Atazanavir
Drug: Atazanavir/Ritonavir
Drug: Tenofovir/Emtricitabine
Drug: Lopinavir/ritonavir

  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
710 participants were enrolled, 709 were treated. The participant who did not receive treatment was enrolled in error having been assigned to efavirenz in the parent study AI424034 (only subjects assigned to ATV rolled over into AI424077).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Atazanavir (ATV) Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
Atazanavir/Ritonavir (ATV/RTV)

Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.

Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)

Lopinavir/Ritonavir (LPV/RTV)

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)


Participant Flow:   Overall Study
    Atazanavir (ATV)   Atazanavir/Ritonavir (ATV/RTV)   Lopinavir/Ritonavir (LPV/RTV)
STARTED   459   154   96 
COMPLETED   367   103   53 
NOT COMPLETED   92   51   43 
Adverse Event                8                5                11 
Death                0                8                1 
Lack of Efficacy                10                2                3 
Lost to Follow-up                30                12                7 
Reasons Not Identified                14                13                8 
Poor/Non-compliance                4                3                2 
Pregnancy                10                2                4 
No Longer Met Study Criteria                4                1                0 
Subject Withdrew Consent                12                5                7 



  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.
All Treated Participants

Reporting Groups
  Description
Atazanavir (ATV) Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
Atazanavir/Ritonavir (ATV/RTV)

Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.

Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)

Lopinavir/Ritonavir (LPV/RTV)

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)

Total Total of all reporting groups

Baseline Measures
   Atazanavir (ATV)   Atazanavir/Ritonavir (ATV/RTV)   Lopinavir/Ritonavir (LPV/RTV)   Total 
Overall Participants Analyzed 
[Units: Participants]
 459   154   96   709 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.6  (9.00)   35.9  (8.81)   37.6  (10.16)   36.6  (9.12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      172  37.5%      54  35.1%      30  31.3%      256  36.1% 
Male      287  62.5%      100  64.9%      66  68.8%      453  63.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
White   158   34   18   210 
Black or African American   112   25   2   139 
American Indian/Alaska Native   1   0   0   1 
Asian   53   13   18   84 
Other   135   82   58   275 


  Outcome Measures

1.  Primary:   Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death   [ Time Frame: Date of First Dose to 30 days post the last dose; approximately 405 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01003990     History of Changes
Other Study ID Numbers: AI424-077
Study First Received: October 20, 2009
Results First Received: February 2, 2017
Last Updated: April 4, 2017