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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961272
• Other study ID #: 09-0889
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: February 27, 2014
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 ß-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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Kristine Patterson, MD	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (7)

Blankson JN, Persaud D, Siliciano RF. The challenge of viral reservoirs in HIV-1 infection. Annu Rev Med. 2002;53:557-93. Review. — View Citation

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

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. Epub 2004 Jul 9. — View Citation

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. Erratum in: J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):492. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the pharmacokinetics of raltegravir in cervicovaginal secretions as compared to blood plasma at steady-state in six HIV-positive women.		one year	No