Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
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
History of Changes
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
  Show Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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
  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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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


Limitations and Caveats
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
No text entered.  


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