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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00961272
First received: August 14, 2009
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Menopause
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-infected, pre-menopausal women

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961272

Locations
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7215
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck
Investigators
Principal Investigator: Kristine Patterson, MD University of North Carolina, Chapel Hill
Principal Investigator: Angela Kashuba, PharmD University of North Carolina, Chapel Hill
  More Information

Publications:

Responsible Party: Kristine Patterson, MD, The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00961272     History of Changes
Other Study ID Numbers: 09-0889
Study First Received: August 14, 2009
Last Updated: May 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Pre-menopausal
Pharmacokinetics
Raltegravir
Women
HIV-infected

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2013