"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

History of Changes

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

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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
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

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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.
No text entered.

Reporting Groups

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

Baseline Measures

	Atazanavir	Fosamprenavir	Total
Number of Participants [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

Outcome Measures

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1. Primary:

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

Measure Type	Primary
Measure Title	Proportion of Patient With Viral Load Less Than 400 Copies/mL
Measure Description	No text entered.
Time Frame	24 weeks
Safety Issue	No

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

	Description
Atazanavir	No text entered.
Fosamprenavir	No text entered.

Measured Values

	Atazanavir	Fosamprenavir
Number of Participants Analyzed [units: participants]	18	15
Proportion of Patient With Viral Load Less Than 400 Copies/mL [units: percentage]	89	73

No statistical analysis provided for Proportion of Patient With Viral Load Less Than 400 Copies/mL

2. Secondary:

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

Measure Type	Secondary
Measure Title	CD4 Cell Count Change From Baseline During Treatment.
Measure Description	No text entered.
Time Frame	24 weeks.
Safety Issue	Yes

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

	Description
Atazanavir	No text entered.
Fosamprenavir	No text entered.

Measured Values

	Atazanavir	Fosamprenavir
Number of Participants Analyzed [units: participants]	18	15
CD4 Cell Count Change From Baseline During Treatment. [units: cell/mm3] Mean (Standard Deviation)	139 (119)	117 (99)

No statistical analysis provided for CD4 Cell Count Change From Baseline During Treatment.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Roberto C. Arduino, Professor of Medicine
Organization: The University of Texas Health Science Center at Houston
phone: 713-500-6731
e-mail: roberto.c.arduino@uth.tmc.edu

Publications of Results:

Holmes A, Lucke J, Maghidman S, Fernandez-Bussy S, Barnett B, Arduino R. Tenofovir associated nephrotoxicity is dose-dependent ritonavir administration a co-factor? XVI International AIDS Conference. Toronto, Canada. August 13-18, 2006. Abstract TUPE0085.

Bell TK, Holmes A, McCormack OE, Barnett BJ, Arduino RC. Changing Genotypic Resistance Patterns and Demographics of Antiretroviral-Naïve HIV Patients in Houston: 1999-2006. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 975.

Holmes A, Bell T, Barnett B, Arduino R. Emerging resistance mutations in once-daily ritonavir-boosted protease inhibitor-containing antiretroviral regimens. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 973.

Other Publications:

Murphy RL, Sanne I, Cahn P, Phanuphak P, Percival L, Kelleher T, Giordano M. Dose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjects: 48-week results. AIDS. 2003 Dec 5;17(18):2603-14.

Sax PE. Meeting notes from the 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment. Atazanavir in treatment-experienced patients. AIDS Clin Care. 2003 Sep;15(9):78.

Bayés M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2003 Jul-Aug;25(6):483-506.

Goldsmith DR, Perry CM. Atazanavir. Drugs. 2003;63(16):1679-93; discussion 1694-5. Review.

Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM, Wannamaker PG. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004 Jan 1;35(1):22-32.

SOLO trial results released. AIDS Patient Care STDS. 2003 Feb;17(2):95.

Falcoz C, Jenkins JM, Bye C, Hardman TC, Kenney KB, Studenberg S, Fuder H, Prince WT. Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers. J Clin Pharmacol. 2002 Aug;42(8):887-98.

Vierling P, Greiner J. Prodrugs of HIV protease inhibitors. Curr Pharm Des. 2003;9(22):1755-70. Review.

Mannheimer SB, Matts J, Telzak E, Chesney M, Child C, Wu AW, Friedland G; Terry Beirn Community Programs for Clinical Research on AIDS. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care. 2005 Jan;17(1):10-22.

Responsible Party:	Roberto Arduino, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00242216 History of Changes
Other Study ID Numbers:	HSC-MS-03-315
Study First Received:	October 18, 2005
Results First Received:	May 2, 2013
Last Updated:	December 12, 2013
Health Authority:	United States: Institutional Review Board

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