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Trial record 21 of 35 for:    " August 29, 2007":" September 28, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

RAL-eve Study: Raltegravir Substitution Study

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ClinicalTrials.gov Identifier: NCT00523237
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : October 28, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Raltegravir
Enrollment 14
Recruitment Details Fourteen patients, all men, were enrolled.
Pre-assignment Details All screened patients were enrolled into the study
Arm/Group Title Raltegravir
Hide Arm/Group Description 400 mg twice daily
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Raltegravir
Hide Arm/Group Description 400 mg twice daily
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
56  (56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
0
   0.0%
Male
14
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
Hide Description evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.
Arm/Group Title Enfuvirtide Switch to Raltegravir Arm
Hide Arm/Group Description:
patients were switched from Enfuvirtide to Raltegravir
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage
86
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir
Hide Arm/Group Description 400 mg twice daily
All-Cause Mortality
Raltegravir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raltegravir
Affected / at Risk (%)
Total   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Philip Grant, MD
Organization: Stanford University
Phone: 650-723-2804
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00523237     History of Changes
Obsolete Identifiers: NCT00627939
Other Study ID Numbers: RAL-eve study
First Submitted: August 29, 2007
First Posted: August 31, 2007
Results First Submitted: July 20, 2011
Results First Posted: October 28, 2011
Last Update Posted: November 2, 2011