Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kristine Patterson, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00961272
First received: August 14, 2009
Last updated: February 27, 2014
Last verified: February 2014

August 14, 2009
February 27, 2014
July 2009
February 2010   (final data collection date for primary outcome measure)
To describe the pharmacokinetics of raltegravir in cervicovaginal secretions as compared to blood plasma at steady-state in six HIV-positive women. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00961272 on ClinicalTrials.gov Archive Site
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Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women
An Open-Label, Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Pre-menopausal Women

The purpose of this study is to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.

Participants: Six HIV-positive pre-menopausal women already undergoing therapy with raltegravir.

Procedures (methods): This study will be conducted at a single site: the University of North Carolina at Chapel Hill. An outpatient screening visit will assess subject suitability and willingness to participate. During one pharmacokinetic visit women will be asked to self-collect cervicovaginal samples using a cervicovaginal fluid aspirator at the following time points: pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours after raltegravir 400mg dose administration. One 3mL EDTA tube will be collected at the same time points to analyze blood plasma. A follow-up safety visit will be completed within 30 days of the inpatient stay.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Six HIV-infected adult pre-menopausal women (> or equal to 18 and less than or equal to 49 years of age) currently undergoing treatment with raltegravir with an intact uterus and cervix will be considered for enrollment. Pregnant women and women testing positive for STDs (bacterial vaginosis, syphilis, gonorrhea, chlamydia, or trichomonas) will be excluded. The six HIV-infected women enrolled in this study will come from the UNC-Chapel Hill Infectious Diseases Clinic and associated clinics in local Health Departments.

HIV Infections
Not Provided
HIV-infected, pre-menopausal women

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infection documented by HIV serology or detectable viral load
  • Able to provide informed consent
  • In the opinion of the investigator, able to comply with their treatment regimen and study procedures
  • Currently receiving raltegravir as treatment for HIV infection. Subjects must have been on raltegravir for at least 3 weeks prior to the inpatient pharmacokinetic sampling stay.
  • All women of reproductive potential (who have not reached menopause or undergone bilateral oophorectomy, or tubal ligation) must have a negative serum β-HCG pregnancy test performed at screening.
  • Subjects must test negative for sexually transmitted infections (gonorrhea, chlamydia, trichomonas, bacterial vaginosis, or syphilis) at screening
  • All study volunteers must agree not to participate in a conception process (e.g., active attempt to become pregnant).
  • Subjects must be willing to abstain from intercourse, and vaginal instrumentation, including douching, within the 48 hours prior to all study visits.
  • If participating in sexual activity that could lead to pregnancy between study visits, 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)

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • 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, or trichomonas
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00961272
09-0889
No
Kristine Patterson, MD, University of North Carolina, Chapel Hill
Kristine Patterson, MD
Merck Sharp & Dohme Corp.
Principal Investigator: Kristine Patterson, MD University of North Carolina, Chapel Hill
Principal Investigator: Angela Kashuba, PharmD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP