Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV

This study has been terminated.
(The DSMB concluded that the findings regarding the primary analysis would persist and that no additional study goals would be achieved by continuing the study.)
Sponsor:
Collaborators:
Adult AIDS Clinical Trials Group
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00090779
First received: September 3, 2004
Last updated: November 16, 2012
Last verified: November 2012
Results First Received: July 2, 2012  
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: Emtricitabine/ tenofovir disoproxil fumarate
Drug: Lopinavir/Ritonavir

  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.
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Reporting Groups
  Description
IT Arm IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
DT Arm DT arm participants received no Treatment
Total Total of all reporting groups

Baseline Measures
    IT Arm     DT Arm     Total  
Number of Participants  
[units: participants]
  66     64     130  
Age  
[units: years]
Mean ± Standard Deviation
  34.1  ± 11.3     34.6  ± 9.1     34.4  ± 10.3  
Age, Customized  
[units: participants]
     
<20 years     4     0     4  
20-29 years     24     23     47  
30-39 years     19     21     40  
40-49 years     12     16     28  
50-59 years     4     4     8  
60-69 years     3     0     3  
Gender  
[units: participants]
     
Female     8     5     13  
Male     58     59     117  
Race  
[units: participants]
     
White     49     56     105  
Black/ African American     10     3     13  
Other     4     4     8  
Unknown     3     1     4  
Ethnicity  
[units: participants]
     
Hispanic or Latino     14     9     23  
Not Hispanic or Latino     52     55     107  
CD4 Counts  
[units: cells/mm3]
Mean ± Standard Deviation
  570  ± 197     611  ± 207     590  ± 202  
CD4 Count Category  
[units: participants]
     
201-350 cells/mm^3     4     2     6  
351-500 cells/mm^3     26     24     50  
>500 cells/mm^3     36     38     74  
Log10 HIV-1 RNA Viral Load  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.4  ± 0.6     4.4  ± 0.6     4.4  ± 0.6  
HIV-1 RNA Viral Load Category  
[units: participants]
     
200-399 copies/mL     0     1     1  
400-999 copies/mL     1     0     1  
1000-9999 copies/mL     16     15     31  
>=10000 copies/mL     49     48     97  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm   [ Time Frame: At Weeks 72 and 76 ]

2.  Primary:   Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm   [ Time Frame: IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40) ]

3.  Primary:   Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.   [ Time Frame: 96 weeks since randomization ]

4.  Secondary:   Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm   [ Time Frame: IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60) ]

5.  Secondary:   Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation   [ Time Frame: 96 weeks since randomization ]

6.  Secondary:   Number of Participants in IT Arm Off Treatment Before 36 Weeks   [ Time Frame: At Week 36 ]

7.  Secondary:   Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation   [ Time Frame: 96 weeks since randomization ]

8.  Secondary:   Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation   [ Time Frame: 96 weeks since randomization ]

9.  Secondary:   Time to Treatment Initiation or Death   [ Time Frame: 5 years since randomization ]


  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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