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ClinicalTrials.gov Identifier: NCT00242216
Recruitment Status : Completed
First Posted : October 19, 2005
Results First Posted : October 17, 2013
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Roberto Arduino, The University of Texas Health Science Center, Houston

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: ritonavir-boosted atazanavir
Drug: ritonavir-boosted fosamprenavir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled at a county clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atazanavir Atazanavir/ritonavir (300mg/100mg) once daily
Fosamprenavir Fosamprenavir/ritonavir (1400mg/100mg) once daily

Participant Flow:   Overall Study
    Atazanavir   Fosamprenavir
STARTED   39   37 
COMPLETED   21   15 
NOT COMPLETED   18   22 
Lost to Follow-up                12                17 
Death                4                2 
Lack of Efficacy                1                2 
no medicaiton dispensed                1                1 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Proportion of Patient With Viral Load Less Than 400 Copies/mL   [ Time Frame: 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   CD4 Cell Count Change From Baseline During Treatment.   [ Time Frame: 24 weeks. ]
  Show Outcome Measure 2


  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
High porportion of subject did not complete the study.


  More Information