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View Clinical Trial (Medical Research Study)
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A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Women - NCT00774683-27514 (Clinical Trial 248091)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy248091.aspx
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| City: |
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Chapel Hill |
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State:
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NC |
| Zip Code: |
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27514 |
| Conditions: |
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HIV - AIDS |
| Purpose: |
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The purpose of this research sub-study is to learn about the levels of an antiretroviral
(ARV) medication called Raltegravir, and response to HIV virus in the genital tract of
HIV-positive women.
We would like to see how this study medication is tolerated, and how the body processes the
study medication in women who are HIV-positive. More specifically, we are interested in how
Isentress® might penetrate into the female cervicovaginal secretions thereby potentially
reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital
secretions may prevent female subjects from transmitting HIV to their sexual partners. This
information will help the research team know how a medication such as Isentress® might be
used to prevent the sexual transmission of HIV.
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| Study summary: |
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Purpose: This study aims to characterize the pharmacokinetics of raltegravir in
cervicovaginal fluids of HIV-infected women, and compare this to the blood plasma
pharmacokinetics being obtained in the main study, CID 0706.
Participants: Six HIV-positive women from the CID 0706 study Procedures: During the
pharmacokinetic visit to obtain blood plasma in the CID 0706 study, women will be asked to
self-collect cervicovaginal samples using a vaginal aspirator at the following timepoints:
pre-dose and 1, 2, 4, 6, 8, and 12 hours after raltegravir 400mg dose administration. |
| Criteria: |
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Inclusion Criteria:
- HIV-1 infection documented by HIV serology or detectable viral load
- Self-described as African-American
- Less than 7 days cumulative of prior HIV therapy
- Plasma HIV RNA PCR equal to or greater than 1000 copies/mL within 90 days prior to
study entry
- Able to provide informed consent
- In the opinion of the investigator, able to comply with study medication and
procedures
- ALT (SGPT) < or equal to 3.0 x ULN within 45 days prior to study entry
- GRF > 60 as calculated by MDRD within 45 days prior to study entry
- All women of reproductive potential (who have not reached menopause or undergone
hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum
or urine β-HCG pregnancy test performed within 48 hours before entry.
All study volunteers must agree not to participate in a conception process (e.g., active
attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and,
if participating in sexual activity that could lead to pregnancy, the female study
volunteer/male partner must use at least one reliable method of contraception (e.g.,
condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide;
an IUD; or hormonal-based contraception), simultaneously while receiving the
protocol-specified medication(s) and for 6 weeks after stopping the medication(s).
Exclusion Criteria:
- Pregnancy
- Breastfeeding
- Prior receipt of Raltegravir
- Any condition which in the opinion of the investigator is likely to interfere with
follow-up or ability to take the study medication appropriately
- A positive test for bacterial vaginosis, syphilis, gonorrhea, Chlamydia, HSV-2
(active lesions), or trichomonas at entry or week 2 of the main study, CID 0706 |
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| Study is available at: |
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The University of North Carolina at Chapel Hill
Chapel Hill, NC 27514
United States
Primary Contact:
Heather M Prince, PA-C
Email: princeh@med.unc.edu
Phone: 919-843-6848
Secondary Contact:
Heather M Prince, PA-C
Email: princeh@med.unc.edu
Phone: 919-843-6848 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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