CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA)

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00050089
First received: November 20, 2002
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: September 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: AIDS
HIV Infections
Interventions: Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Drug: Standard ART vs Mega ART

  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
A total of 368 participants were enrolled in the trial: 41 in Canada, 39 in the UK and 288 in the US-VA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
339 participants were randomized to factorial design(Canada=41;UK=10;US-VA=288). 29 participants in the UK were enrolled in a protocol-approved option, where they were allowed to select one of the factors and be randomized to the other. All 29 selected the ARDFP vs No ARDFP factor and were randomized to the Standard-ART vs Mega-ART factor.

Reporting Groups
  Description
No ARDFP+Standard-ART

No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART

Standard-ART: up to 4 anti-HIV drugs

No ARDFP+Mega-ART

No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART

Mega-ART: 5 or more anti-HIV drugs

ARDFP+Standard-ART

Antiretroviral Drug-Free Period (ARDFP) and Standard-ART

Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs

ARDFP+Mega-ART

Antiretroviral Drug-Free Period (ARDFP) and Mega-ART

Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs


Participant Flow:   Overall Study
    No ARDFP+Standard-ART     No ARDFP+Mega-ART     ARDFP+Standard-ART     ARDFP+Mega-ART  
STARTED     106     98     86     78  
Baseline     91 [1]   84 [2]   86     78  
COMPLETED     106 [3]   98 [3]   86 [3]   78 [3]
NOT COMPLETED     0     0     0     0  
[1] 15 participants randomized in the UK Option scheme (not displayed in the 2X2 baseline data)
[2] 14 participants randomized in the UK Option scheme (not shown in 2X2 baseline data)
[3] For primary outcome assessment



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Participants Who Developed a New or Recurrent AIDS Event or Death   [ Time Frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years ]

2.  Primary:   Participants Who Developed a New or Recurrent AIDS Event or Death   [ Time Frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years ]

3.  Primary:   Participants Who Developed a New or Recurrent AIDS Event or Death   [ Time Frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years ]


  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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