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

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. Identifier: NCT00414518
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : February 20, 2013
Last Update Posted : February 20, 2013
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver

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

  Baseline Characteristics

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
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   7   9   16 
>=65 years   0   0   0 
[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

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

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.

  More Information

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 )
First Submitted: December 19, 2006
First Posted: December 21, 2006
Results First Submitted: September 6, 2012
Results First Posted: February 20, 2013
Last Update Posted: February 20, 2013