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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:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00414518
First received: December 19, 2006
Last updated: January 16, 2013
Last verified: January 2013
Results First Received: September 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
No text entered.

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.
No text entered.

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

Measure Type Primary
Measure Title Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
Measure Description No text entered.
Time Frame At Week 24  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
12 Week Treatment Arm Followed by 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 Therapyh 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

Measured Values
    12 Week Treatment Arm Followed by Treatment Interruption     CD4 T Cell Guided Therapyh  
Number of Participants Analyzed  
[units: participants]
  7     9  
Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms  
[units: Log 10 copies of virus/ml]
Mean ± Standard Deviation
  4.8627  ± 0.9055     4.2620  ± 1.0867  

No statistical analysis provided for Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms



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 ]

Measure Type Primary
Measure Title Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
Measure Description No text entered.
Time Frame At Week 24  
Safety Issue Yes  

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.
No text entered.

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

Measured Values
    Arm A     Arm B  
Number of Participants Analyzed  
[units: participants]
  7     9  
Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome  
[units: participants]
  1     1  

No statistical analysis provided for Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome



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

Measure Type Primary
Measure Title Viral Set Point
Measure Description set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus
Time Frame Throughout study  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
12 Week Treatment Folllowed by 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

Measured Values
    12 Week Treatment Folllowed by Treatment Interruption     CD4 T Cell Guided Therapy  
Number of Participants Analyzed  
[units: participants]
  7     9  
Viral Set Point  
[units: Log 10 copies virus/ml]
Mean ± Standard Deviation
  4.8627  ± 0.9055     4.2434  ± 0.7992  

No statistical analysis provided for Viral Set Point




  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michelle A. Barron
Organization: University of Colorado Denver
phone: 303-724-4939
e-mail: michelle.barron@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00414518     History of Changes
Obsolete Identifiers: NCT00525070, NCT01030172
Other Study ID Numbers: 06-0757, P01AI055356
Study First Received: December 19, 2006
Results First Received: September 6, 2012
Last Updated: January 16, 2013
Health Authority: United States: Federal Government