Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01293123
Recruitment Status : Terminated (Did not meet enrollment goals)
First Posted : February 10, 2011
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Scott Letendre, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: Raltegravir
Drug: Efavirenz
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description Raltegravir: raltegravir 400 mg PO twice daily Efavirenz: efavirenz 600 mg PO once daily
Period Title: Overall Study
Started 1 1
Completed 1 0
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Raltegravir Efavirenz Total
Hide Arm/Group Description Raltegravir: raltegravir 400 mg PO twice daily Efavirenz: efavirenz 600 mg PO once daily Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
26  (0) 36  (0) 31  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Cerebrospinal Fluid HIV RNA Levels
Hide Description Slope of decline of HIV RNA levels in CSF over time
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient enrollment for data analysis
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description:
Raltegravir: raltegravir 400 mg PO twice daily
Efavirenz: efavirenz 600 mg PO once daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Neuropsychological Performance
Hide Description Change in neuropsychological performance over 180 days
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient enrollment for data analysis
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description:
Raltegravir: raltegravir 400 mg PO twice daily
Efavirenz: efavirenz 600 mg PO once daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Measure of Mood
Hide Description Change in mood over 180 days
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient enrollment for data analysis
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description:
Raltegravir: raltegravir 400 mg PO twice daily
Efavirenz: efavirenz 600 mg PO once daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Measure of Sleep
Hide Description Change in self-reported sleep performance over 180 days.
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient enrollment for data analysis
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description:
Raltegravir: raltegravir 400 mg PO twice daily
Efavirenz: efavirenz 600 mg PO once daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Measure of Quality of Life
Hide Description Change in self-report quality of life over 180 days
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient enrollment for data analysis
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description:
Raltegravir: raltegravir 400 mg PO twice daily
Efavirenz: efavirenz 600 mg PO once daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir Efavirenz
Hide Arm/Group Description Raltegravir: raltegravir 400 mg PO twice daily Efavirenz: efavirenz 600 mg PO once daily
All-Cause Mortality
Raltegravir Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Raltegravir Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raltegravir Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Letendre, Principal Investigator
Organization: University of California, San Diego
Phone: 6195438080
EMail: sletendre@ucsd.edu
Layout table for additonal information
Responsible Party: Scott Letendre, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01293123    
Other Study ID Numbers: 11-0067
First Submitted: February 9, 2011
First Posted: February 10, 2011
Results First Submitted: October 8, 2019
Results First Posted: October 31, 2019
Last Update Posted: October 31, 2019