A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen

This study has been completed.

Sponsor:

Collaborators:

Merck Sharp & Dohme Corp.

St. Joseph's Hospital, Florida

Information provided by (Responsible Party):

University of South Florida

ClinicalTrials.gov Identifier:

NCT00749580

First received: September 5, 2008

Last updated: December 2, 2014

Last verified: June 2014

History of Changes

Results First Received: March 27, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Virus Diseases HIV
Intervention:	Drug: Switch NRTIs as a Backbone to Raltegravir

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
Participants were recruited from the HIllsborough County Health Department, and Tampa Care Clinic, Tampa, Florida.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Per the inclusion and exclusion criteria

Reporting Groups

	Description
Switched	Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
Controlled	Group 2 Continue the same regimen without change

Participant Flow: Overall Study

	Switched	Controlled
STARTED	21 ^[1]	25
COMPLETED	17 ^[2]	16
NOT COMPLETED	4	9
Lost to Follow-up	4	8
Adverse Event	0	1

^[1]	September 2008
^[2]	December 2010

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
1: Boosted PI+RAL	Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
2: Boosted PI+NRTIs	Group 2 Continue the same regimen without change
Total	Total of all reporting groups

Baseline Measures

	1: Boosted PI+RAL	2: Boosted PI+NRTIs	Total
Overall Participants Analyzed [Units: Participants]	21	25	46

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	21	25	46
>=65 years	0	0	0

Age [Units: Years] Mean (Standard Deviation)	45 (9)	49 (8)	47 (9)

Gender [Units: Participants]
Female	6	6	12
Male	15	19	34

Region of Enrollment [Units: Participants]
United States	21	25	46

Outcome Measures

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1. Primary:

Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen [ Time Frame: at 24weeks for each patient ]

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2. Secondary:

Virologic Suppression of < 75 Copies/ml at 48 Weeks [ Time Frame: at 48 weeks for each patient ]

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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
This is a pilot study and has a small sample size.

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: Charurut Somboonwit, MD
Organization: USF Health
phone: 813 3078067
e-mail: csomboon@health.usf.edu

Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00749580 History of Changes
Obsolete Identifiers:	NCT00717964
Other Study ID Numbers:	Merck-MK0518
Study First Received:	September 5, 2008
Results First Received:	March 27, 2014
Last Updated:	December 2, 2014

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