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The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)

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ClinicalTrials.gov Identifier: NCT00641641
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : May 27, 2013
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sally Hough, Kirby Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Intervention Drug: Tenofovir + emtricitabine + raltegravir.
Enrollment 16
Recruitment Details Patients were recruited at 5 clinical centres in Sydney
Pre-assignment Details A screening period of less than 42 days prior to commencement of study drugs was employed
Arm/Group Title Drug Intervention
Hide Arm/Group Description Tenofovir+emtricitabine+raltegravir
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Drug Intervention
Hide Arm/Group Description Tenofovir+emtricitabine+raltegravir
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 16 participants
16
1.Primary Outcome
Title Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
Hide Description change was calculated as the mean of 12 assessments minus the baseline value
Time Frame 12 times within 48 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Drug Intervention
Hide Arm/Group Description:
Tenofovir+emtricitabine+raltegravir
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log copies/mL plasma
5.4  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug Intervention
Hide Arm/Group Description Tenofovir+emtricitabine+raltegravir
All-Cause Mortality
Drug Intervention
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Drug Intervention
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Drug Intervention
Affected / at Risk (%)
Total   0/16 (0.00%) 
Limited cohort (n=16) of exclusively male participants treated with a licensed regimen of combination antiretroviral therapy with the primary focus being a detailed examination of virus decay characteristics
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sean Emery
Organization: University of New South Wales
Phone: 9385 0900
Responsible Party: Sally Hough, Kirby Institute
ClinicalTrials.gov Identifier: NCT00641641     History of Changes
Other Study ID Numbers: PINT01
First Submitted: February 28, 2008
First Posted: March 24, 2008
Results First Submitted: April 11, 2012
Results First Posted: May 27, 2013
Last Update Posted: August 31, 2017