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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


  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.
HIV-positive patients with a CD4 count <=300 cells/ul who had prior anti-retroviral treatment failure requiring retreatment

Reporting Groups
  Description
No ARDFP + Standard ART Standard Antiretroviral Treatment regimen
No ARDFP + Mega ART Intensive Antiretroviral Treatment regimen
ARDFP + Standard ART Antiretroviral Treatment Interruption and Standard ART
ARDFP + Mega ART Antiretroviral Treatment Interruption and Intensive ART
Total Total of all reporting groups

Baseline Measures
    No ARDFP + Standard ART     No ARDFP + Mega ART     ARDFP + Standard ART     ARDFP + Mega ART     Total  
Number of Participants  
[units: participants]
  91     84     86     78     339  
Age  
[units: years]
Mean ± Standard Deviation
  48.7  ± 8.99     48.3  ± 7.92     49.2  ± 8.1     48.2  ± 8.58     48.6  ± 8.39  
Age, Customized  
[units: participants]
         
31-40 years     16     11     12     15     54  
41-50 years     35     41     36     30     142  
51-60 years     33     28     31     28     120  
>60 years     7     4     7     5     23  
Gender  
[units: participants]
         
Female     1     2     2     2     7  
Male     90     82     84     76     332  
Race/Ethnicity, Customized  
[units: participants]
         
White     42     45     38     35     160  
Black     41     30     36     31     138  
Asian     1     0     0     0     1  
Hispanic     6     9     9     12     36  
Aboriginal     1     0     1     0     2  
Other     0     0     2     0     2  
Region of Enrollment  
[units: participants]
         
United States     77     71     73     67     288  
United Kingdom     2     2     3     3     10  
Canada     12     11     10     8     41  
log10 Viral Load  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.76  ± 0.55     4.75  ± 0.76     4.64  ± 0.67     4.7  ± 0.75     4.71  ± 0.68  
CD4 cells/mm3  
[units: cells/mm^3]
Mean ± Standard Deviation
  136  ± 112     127  ± 107     130  ± 106     127  ± 106     130  ± 108  
CD4 level  
[units: participants]
         
CD4 <=100 cells/mm^3     38     38     36     33     145  
CD4 >100 cells/mm^3     53     46     50     45     194  
Mode of HIV Infection  
[units: participants]
         
Blood     12     7     8     7     34  
Heterosexual     20     19     22     19     80  
Intravenous Drug Use (IVDU)     11     16     15     9     51  
Men who have Sex with Men (MSM)     42     37     37     39     155  
Other     6     5     2     4     17  
Unknown     0     0     2     0     2  
AIDS at entry [1]
[units: participants]
         
Yes     59     46     44     51     200  
No     32     38     42     27     139  
Hepatitis B (HBsAg)  
[units: participants]
         
Yes     10     4     15     8     37  
No     81     80     71     70     302  
Hepatitis C (Hep C anti-HCV)  
[units: participants]
         
Yes     17     21     27     12     77  
No     74     63     59     66     262  
OI medications for prophylaxis [2]
[units: participants]
         
Anti-PCP     75     67     71     62     275  
Anti-CMV     2     0     2     0     4  
Antibacterial     43     39     33     37     152  
Antifungal     22     23     22     19     86  
Concomitant Medications [3]
[units: participants]
         
Lipid Lowering     24     20     33     21     98  
Other antiviral     43     30     30     33     136  
[1] History of AIDS event at study entry
[2] Opportunistic Infections medications for prophylaxis at study entry
[3] Not all study participants were on other Concomitant Medications. Numbers provided represent participants on those medications at baseline.



  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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