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Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

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ClinicalTrials.gov Identifier: NCT00632970
Recruitment Status : Terminated (no patients completed)
First Posted : March 11, 2008
Results First Posted : June 26, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Simon, George Washington University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Raltegravir
Drug: Lopinavir/Ritonavir
Drug: Truvada
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raltegravir Lopinavir/Ritonavir
Hide Arm/Group Description Patients with HIV infection randomized to receive raltegravir with truvada Patients with HIV infection randomized to receive lopinavir/ritonavir with truvada
Period Title: Overall Study
Started 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title Raltegravir Lopinavir/Ritonavir Total
Hide Arm/Group Description Raltegravir: 1 400mg tablet twice a day Lopinavir/Ritonavir: 2 tablets twice a day Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
6
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  66.7%
1
  33.3%
3
  50.0%
White
1
  33.3%
2
  66.7%
3
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
 100.0%
3
 100.0%
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
HIV seropositive with viral load < 10,000  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Absolute Change in CD4 Cell Counts
Hide Description [Not Specified]
Time Frame 24 and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir Lopinavir/Ritonavir
Hide Arm/Group Description:
Raltegravir: 1 400mg tablet twice a day
Lopinavir/Ritonavir: 2 tablets twice a day
Overall Number of Participants Analyzed 3 3
Mean (Full Range)
Unit of Measure: cells/mm^3
50
(10 to 150)
50
(20 to 120)
2.Secondary Outcome
Title Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data can not be reported because the samples were never analyzed and therefore no data was analyzed.
Arm/Group Title Raltegravir Lopinavir/Ritonavir
Hide Arm/Group Description:
Raltegravir: 1 400mg tablet twice a day
Lopinavir/Ritonavir: 2 tablets twice a day
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir Lopinavir/Ritonavir
Hide Arm/Group Description Raltegravir: 1 400mg tablet twice a day Lopinavir/Ritonavir: 2 tablets twice a day
All-Cause Mortality
Raltegravir Lopinavir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir Lopinavir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir Lopinavir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
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: Gary Simon
Organization: Medical Faculty Associates
Phone: 202 741-2234
Responsible Party: Gary Simon, George Washington University
ClinicalTrials.gov Identifier: NCT00632970     History of Changes
Other Study ID Numbers: GS001
First Submitted: February 29, 2008
First Posted: March 11, 2008
Results First Submitted: March 4, 2014
Results First Posted: June 26, 2017
Last Update Posted: August 29, 2018