NCT00961272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

August 14, 2009

Last Update Submit

February 27, 2014

Conditions

HIV Infections

Keywords

Pre-menopausalPharmacokineticsRaltegravirWomenHIV-infected

Outcome Measures

Primary Outcomes (1)

  • To describe the pharmacokinetics of raltegravir in cervicovaginal secretions as compared to blood plasma at steady-state in six HIV-positive women.

    one year

Study Arms (1)

HIV-infected, pre-menopausal women

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7215, United States

Location

Related Publications (8)

  • Musicco M, Lazzarin A, Nicolosi A, Gasparini M, Costigliola P, Arici C, Saracco A. Antiretroviral treatment of men infected with human immunodeficiency virus type 1 reduces the incidence of heterosexual transmission. Italian Study Group on HIV Heterosexual Transmission. Arch Intern Med. 1994 Sep 12;154(17):1971-6.

    PMID: 8074601BACKGROUND

  • Otten RA, Smith DK, Adams DR, Pullium JK, Jackson E, Kim CN, Jaffe H, Janssen R, Butera S, Folks TM. Efficacy of postexposure prophylaxis after intravaginal exposure of pig-tailed macaques to a human-derived retrovirus (human immunodeficiency virus type 2). J Virol. 2000 Oct;74(20):9771-5. doi: 10.1128/jvi.74.20.9771-9775.2000.

    PMID: 11000253BACKGROUND

  • Lallemant M, Jourdain G, Le Coeur S, Mary JY, Ngo-Giang-Huong N, Koetsawang S, Kanshana S, McIntosh K, Thaineua V; Perinatal HIV Prevention Trial (Thailand) Investigators. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004 Jul 15;351(3):217-28. doi: 10.1056/NEJMoa033500. Epub 2004 Jul 9.

    PMID: 15247338BACKGROUND

  • Blankson JN, Persaud D, Siliciano RF. The challenge of viral reservoirs in HIV-1 infection. Annu Rev Med. 2002;53:557-93. doi: 10.1146/annurev.med.53.082901.104024.

    PMID: 11818490BACKGROUND

  • Pierson T, Hoffman TL, Blankson J, Finzi D, Chadwick K, Margolick JB, Buck C, Siliciano JD, Doms RW, Siliciano RF. Characterization of chemokine receptor utilization of viruses in the latent reservoir for human immunodeficiency virus type 1. J Virol. 2000 Sep;74(17):7824-33. doi: 10.1128/jvi.74.17.7824-7833.2000.

    PMID: 10933689BACKGROUND

  • Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956.

    PMID: 17133211BACKGROUND

  • Cohen MS. Preventing sexual transmission of HIV. Clin Infect Dis. 2007 Dec 15;45 Suppl 4:S287-92. doi: 10.1086/522552.

    PMID: 18190301BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kristine Patterson, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Angela Kashuba, PharmD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor of Medicine

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 18, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

US(1)