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

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
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;   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
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 

  Baseline Characteristics

  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
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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


Responsible Party: University of Colorado, Denver Identifier: NCT00414518     History of Changes
Obsolete Identifiers: NCT00525070, NCT01030172
Other Study ID Numbers: 06-0757
P01AI055356 ( U.S. NIH Grant/Contract )
Study First Received: December 19, 2006
Results First Received: September 6, 2012
Last Updated: January 16, 2013