|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00666055 |
Purpose
The purpose of this research study is to learn about levels of antiretroviral drug levels and response to HIV virus in the genital tract of women who are post-menopausal. The investigators in this study think that the levels of hormones post-menopausal HIV-infected women may have in their bodies may affect the levels of antiretroviral drug, and therefore affect how much HIV virus they have in their bodies. Since women who have already gone through menopause have different levels of hormones, such as estrogen, than women who are pre-menopausal, the investigators would like to check the levels of antiretroviral drugs in their blood, their genital secretions, and their genital tissue.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: ARV regimen chosen by treating physician |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics |
blood; genital secretions; genital tissue
| Estimated Enrollment: | 42 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
30 post-menopausal HIV-infected women
|
Drug: ARV regimen chosen by treating physician
Women may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir). Provided the ARV regimens contain one or more of the agents under study they may also include new agents such as maraviroc (CCR5 inhibitor), raltegravir (integrase inhibitor) and/or etravirine (NNRTI). Other Names:
|
|
Group 2
12 pre-menopausal HIV-infected women
|
Drug: ARV regimen chosen by treating physician
Women may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir). Provided the ARV regimens contain one or more of the agents under study they may also include new agents such as maraviroc (CCR5 inhibitor), raltegravir (integrase inhibitor) and/or etravirine (NNRTI). Other Names:
|
Purpose: To longitudinally quantify systemic and genital tract antiretroviral pharmacokinetics and viral responses in HIV-infected post-menopausal women. These parameters will be compared to pre-menopausal women to determine if the absence or presence of estrogen influences treatment responses and infectiousness of HIV.
Participants: 30 post-menopausal and 12 pre-menopausal HIV-infected women Procedures (methods): First dose, steady state, and longitudinal pharmacokinetics of the most commonly prescribed antiretroviral agents will be assessed in the systemic and genital tract compartments in a cohort of post- and pre-menopausal HIV-infected women. Concurrent blood plasma and genital secretions HIV RNA will be measured. Systemic and genital tract virologic responses will be correlated with antiretroviral concentrations and with each other.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects will primarily be recruited from the UNC Infectious Disease Clinic and the Wake County HIV Clinic.
Inclusion Criteria:
Menopause status will be determined at screening.
Exclusion Criteria:
Contacts and Locations| Contact: Heather A Prince, PA | 919-843-6848 | princeh@med.unc.edu |
| United States, North Carolina | |
| The University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7215 | |
| Contact: Heather A Prince, PA-C 919-843-6848 princeh@med.unc.edu | |
| Principal Investigator: Kristine B Patterson, MD | |
| Sub-Investigator: Joseph Eron, MD | |
| Sub-Investigator: Angela Kashuba, PharmD | |
| Sub-Investigator: Gretchen Stuart, MD | |
| Principal Investigator: | Kristine B Patterson, MD | University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | Kristine Patterson, MD, The University of North Carolina at Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00666055 History of Changes |
| Other Study ID Numbers: | CID 0708, 1K23AI077355-01 |
| Study First Received: | April 22, 2008 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Federal Government |
|
Sex Aging Antiretroviral |
Pharmacokinetics post-menopausal women with HIV infection pre-menopausal women with HIV infection |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Tenofovir Efavirenz |
Ritonavir Atazanavir Emtricitabine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors |
