Status:
COMPLETED
Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract
Lead Sponsor:
University of Colorado, Denver
Conditions:
Women's Health
HIV Infection
Eligibility:
FEMALE
18-80 years
Brief Summary
Increases in cluster of differentiation 4 (CD4)+ T cells in the blood is well documented in human immunodeficiency virus (HIV)-infected individuals after starting antiretroviral therapy (ART), but inc...
Eligibility Criteria
Inclusion
- HIV-1 seropositive women receiving a RAL-based regimen (n=20) and women receiving an atazanavir-based regimen (n=20).
- Women will be recruited to this study from the Denver metropolitan area.
- The women must have a plasma HIV RNA \<48 copies/mL for at least 6 months on the same antiretroviral regimen, and a CD4+ T cell count \> 300 cell/mm3.
- Transient increases of \<=200 copies HIV-1 RNA copies/ mL will be allowed.
Exclusion
- Hysterectomy
- No a menstrual cycle for 12 months
- Active substance abuse
- hematocrit (HCT) \<30
- Bleeding diathesis
- Known carcinoma of the cervix
- Using oral glucocorticoids or other immunosuppressive agents
- Current pregnancy
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01456962
Start Date
October 1 2011
End Date
August 1 2013
Last Update
June 9 2017
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045