"The Once A Day Protease Inhibitor Regimens"

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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

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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
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
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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

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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.
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Reporting Groups

	Description
Atazanavir	No text entered.
Fosamprenavir	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Atazanavir	Fosamprenavir	Total
Overall Participants Analyzed [Units: Participants]	39	37	76

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	38	33	71
>=65 years	1	4	5

Age [Units: Years] Mean (Standard Deviation)	48 (9.7)	48 (10)	48 (10)

Gender [Units: Participants]
Female	11	9	20
Male	28	28	56

Region of Enrollment [Units: Participants]
United States	39	37	76