A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected 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:
NCT00774683
First received: October 15, 2008
Last updated: October 21, 2011
Last verified: October 2011

October 15, 2008
October 21, 2011
August 2008
September 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: Single Time Point Measurement at 4 Weeks after ART Initiation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00774683 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
Not Provided
 
A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women
A Phase IV, Open-Label, Single-Sequence Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Women

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood specimens and cervicovaginal fluids

Non-Probability Sample

UNC ID Clinic, Durham County Health Department, Wake County Health Department

  • HIV
  • AIDS
Drug: Raltegravir (Isentress®)
400 mg p.o. BID x 7 days
Other Names:
  • ISENTRESS
  • MK-0518
Sub-study Group A
Six HIV-positive African American women from the main study, CID 0706
Intervention: Drug: Raltegravir (Isentress®)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00774683
CID 0706 Sub-study A
No
Kristine Patterson, MD, University of North Carolina, Chapel Hill
Kristine Patterson, MD
Merck Sharp & Dohme Corp.
Principal Investigator: Kristine B Patterson, MD University of North Carolina, Chapel Hill
Principal Investigator: Angela DM Kashuba, PharmD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
October 2011

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