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Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414518
First Posted: December 21, 2006
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver
Results First Submitted: September 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tenofovir disoproxil fumarate/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
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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
Treatment Interruption Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
CD4 T Cell Guided Therapy Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements

Participant Flow:   Overall Study
    Treatment Interruption   CD4 T Cell Guided Therapy
STARTED   7   9 
COMPLETED   7   9 
NOT COMPLETED   0   0 



  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
Arm A Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
Arm B Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   9   16 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   9   16 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   3   5   8 
Male   4   4   8 
Region of Enrollment 
[Units: Participants]
     
United States   3   4   7 
Zimbabwe   4   5   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms   [ Time Frame: At Week 24 ]

2.  Primary:   Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome   [ Time Frame: At Week 24 ]

3.  Primary:   Viral Set Point   [ Time Frame: Throughout study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information