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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01456962
First received: October 6, 2011
Last updated: June 8, 2015
Last verified: December 2014
Results First Received: 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.
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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.
Total Total of all reporting groups

Baseline Measures
    Raltegravir Group     Atazanavir Group     Total  
Number of Participants  
[units: participants]
  14     19     33  
Age  
[units: years]
Mean (Full Range)
  44   (31 to 53)     43   (28 to 65)     43   (28 to 65)  
Gender  
[units: participants]
     
Female     14     19     33  
Male     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: Subjects were on treatment from 6 months to 10 years. Subjects were required to be on one of the antiretroviral treatment combinations for at least 6 months for study entry. ]


  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


No publications provided


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01456962     History of Changes
Other Study ID Numbers: 11-1265, 39423
Study First Received: October 6, 2011
Results First Received: May 18, 2015
Last Updated: June 8, 2015
Health Authority: United States: Institutional Review Board