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Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456962
First Posted: October 21, 2011
Last Update Posted: June 9, 2017
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.
Information provided by (Responsible Party):
University of Colorado, Denver
Results First Submitted: May 18, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Women's Health
HIV Infection
Genital Diseases, Female

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Raltegravir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
Atazanavir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.

Participant Flow:   Overall Study
    Raltegravir Group   Atazanavir Group
STARTED   16   20 
COMPLETED   14   19 
NOT COMPLETED   2   1 
Lost to Follow-up                2                1 



  Baseline Characteristics
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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 Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
Atazanavir Group HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
Total Total of all reporting groups

Baseline Measures
   Raltegravir Group   Atazanavir Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   19   33 
Age 
[Units: Years]
Mean (Full Range)
 44 
 (31 to 53) 
 43 
 (28 to 65) 
 43 
 (28 to 65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14 100.0%      19 100.0%      33 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   14   19   33 


  Outcome Measures

1.  Primary:   CD4+ to CD8+ T Cell Ratio in Cervical Biopsies   [ Time Frame: 12 hours after the last medication dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Peter Anderson, Pharm D
Organization: University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences
phone: 303-724-6128
e-mail: peter.anderson@ucdenver.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01456962     History of Changes
Other Study ID Numbers: 11-1265
39423 ( Other Grant/Funding Number: Merck )
First Submitted: October 6, 2011
First Posted: October 21, 2011
Results First Submitted: May 18, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 9, 2017