"The Once A Day Protease Inhibitor Regimens"

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Roberto Arduino, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT00242216

First received: October 18, 2005

Last updated: December 12, 2013

Last verified: December 2013

Results First Received: May 2, 2013

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: 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
None.

Reporting Groups

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

Participant Flow: Overall Study

Baseline Characteristics

Outcome Measures

1. Primary:

Proportion of Patient With Viral Load Less Than 400 Copies/mL [ Time Frame: 24 weeks ]

2. Secondary:

CD4 Cell Count Change From Baseline During Treatment. [ Time Frame: 24 weeks. ]

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