This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
(no patients completed)
Sponsor:
Information provided by (Responsible Party):
Gary Simon, George Washington University
ClinicalTrials.gov Identifier:
NCT00632970
First received: February 29, 2008
Last updated: June 23, 2017
Last verified: June 2017
Results First Received: March 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: Lopinavir/Ritonavir
Drug: Truvada

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Raltegravir Patients with HIV infection randomized to receive raltegravir with truvada
Lopinavir/Ritonavir Patients with HIV infection randomized to receive lopinavir/ritonavir with truvada

Participant Flow:   Overall Study
    Raltegravir   Lopinavir/Ritonavir
STARTED   3   3 
COMPLETED   3   3 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Raltegravir Raltegravir: 1 400mg tablet twice a day
Lopinavir/Ritonavir Lopinavir/Ritonavir: 2 tablets twice a day
Total Total of all reporting groups

Baseline Measures
   Raltegravir   Lopinavir/Ritonavir   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   6 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      3 100.0%      3 100.0%      6 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   3   3   6 
HIV seropositive with viral load < 10,000 
[Units: Participants]
 3   3   6 


  Outcome Measures

1.  Primary:   Absolute Change in CD4 Cell Counts   [ Time Frame: 24 and 48 weeks ]

2.  Secondary:   Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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
e-mail: Gsimon@mfa.gwu.edu



Responsible Party: Gary Simon, George Washington University
ClinicalTrials.gov Identifier: NCT00632970     History of Changes
Other Study ID Numbers: GS001
Study First Received: February 29, 2008
Results First Received: March 4, 2014
Last Updated: June 23, 2017