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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00961272
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : February 28, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kristine Patterson, MD, University of North Carolina, Chapel Hill

Brief Summary:
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 or disease
HIV Infections

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.

Study Type : Observational
Actual Enrollment : 6 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Menopause

HIV-infected, pre-menopausal women

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00961272

United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7215
Sponsors and Collaborators
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

Isentress (raltegravir) Prescribing Guide. Merck & Co, Inc. October 2007

Responsible Party: Kristine Patterson, MD, Clinical Associate Professor of Medicine, University of North Carolina, Chapel Hill Identifier: NCT00961272     History of Changes
Other Study ID Numbers: 09-0889
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Kristine Patterson, MD, University of North Carolina, Chapel Hill:

Additional relevant MeSH terms:
HIV Infections
Anti-HIV Agents
HIV Integrase Inhibitors
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action