RAL-eve Study: Raltegravir Substitution Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT00523237

First received: August 29, 2007

Last updated: October 31, 2011

Last verified: October 2011

Results First Received: July 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Intervention:	Drug: Raltegravir

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Fourteen patients, all men, were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All screened patients were enrolled into the study

Reporting Groups

	Description
Raltegravir	400 mg twice daily

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Raltegravir	400 mg twice daily

Baseline Measures

	Raltegravir
Number of Participants [units: participants]	14
Age [units: participants]
<=18 years	0
Between 18 and 65 years	14
>=65 years	0
Age [units: years] Mean ± Standard Deviation	56 ± 56
Gender [units: participants]
Female	0
Male	14
Region of Enrollment [units: participants]
United States	14

Outcome Measures

1. Primary:

The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir [ Time Frame: 24 weeks ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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Results Point of Contact:

Name/Title: Philip Grant, MD
Organization: Stanford University
phone: 650-723-2804
e-mail: pmgrant@stanford.edu

Publications of Results:

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT00523237 History of Changes
Obsolete Identifiers:	NCT00627939
Other Study ID Numbers:	RAL-eve study
Study First Received:	August 29, 2007
Results First Received:	July 20, 2011
Last Updated:	October 31, 2011
Health Authority:	United States: Food and Drug Administration