Measurement of Plasma and Intracellular Concentrations of Raltegravir

NCT01214486 | Completed

• 1 other identifier: 506-10-FB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to analyze and compare plasma and intracellular concentrations of Raltegravir (RAL) in blood plasma and in peripheral blood mononuclear cells, using high performance liquid chromatography (HPLC).

Conditions

HIV

Keywords

HIV; RAL; Raltegravir; Isentress; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Concentrations of RAL in blood cells.

  Analyze and compare plasma and intracellular concentrations of RAL in blood plasma and in peripheral blood mononuclear cells, using high performance liquid chromatography (HPLC).

  one month

• Concentrations of RAL in blood plasma.

  Analyze and compare plasma and intracellular concentrations of RAL in blood plasma and in peripheral blood mononuclear cells, using high performance liquid chromatography (HPLC).

  one month

Secondary Outcomes (4)

• Pharmacokinetic variability of plasma concentrations of the drug.

  one month

• Pharmacokinetic variability of intracellular concentrations of the drug.

  one month

• Trough concentrations of the drug when dosed twice daily versus once daily.

  one month

• Pharmacokinetics of the drug when dosed twice daily versus once daily.

  One month

Study Arms (1)

Raltegravir

EXPERIMENTAL

Drug: Raltegravir

Interventions

Raltegravir DRUG

Subjects should be on RAL 400mg twice daily at least 1 week. Subjects will be asked to come to the Specialty Clinic at two different points on the same day: at either 2, 4 or 6 hours after taking the drug, and at 10 or 12 hours after taking the drug. After completion of the first part of the study, subjects whose viral load is below the limit of detection (HIV RNA \< 50 copies/mL) will be asked to switch to once a day RAL dosing (i.e. 800 mg once a day). Once the a subject has taken RAL once a day for at least three consecutive days, s/he will be asked to come to the Specialty Clinic at two different points in the same day to obtain blood by venous puncture. Blood will be obtained 2 or 4 hours after the dose and at 20-24 hours after the dose.

Also known as: RAL, Isentress

Raltegravir

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of age greater than or equal to 19 years
• Have documented HIV
• Be taking RAL for at least 7 days

You may not qualify if:

• Any acute intercurrent illness that might interfere with the interpretation of the study

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (9)

• Thompson MA, Aberg JA, Cahn P, Montaner JS, Rizzardini G, Telenti A, Gatell JM, Gunthard HF, Hammer SM, Hirsch MS, Jacobsen DM, Reiss P, Richman DD, Volberding PA, Yeni P, Schooley RT; International AIDS Society-USA. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA. 2010 Jul 21;304(3):321-33. doi: 10.1001/jama.2010.1004.

  PMID: 20639566 BACKGROUND

• Hicks C, Gulick RM. Raltegravir: the first HIV type 1 integrase inhibitor. Clin Infect Dis. 2009 Apr 1;48(7):931-9. doi: 10.1086/597290.

  PMID: 19231980 BACKGROUND

• 3. http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf

  BACKGROUND

• de Maat MM, Huitema AD, Mulder JW, Meenhorst PL, van Gorp EC, Mairuhu AT, Beijnen JH. Subtherapeutic antiretroviral plasma concentrations in routine clinical outpatient HIV care. Ther Drug Monit. 2003 Jun;25(3):367-73. doi: 10.1097/00007691-200306000-00018.

  PMID: 12766566 BACKGROUND

• Powderly WG, Saag MS, Chapman S, Yu G, Quart B, Clendeninn NJ. Predictors of optimal virological response to potent antiretroviral therapy. AIDS. 1999 Oct 1;13(14):1873-80. doi: 10.1097/00002030-199910010-00009.

  PMID: 10513645 BACKGROUND

• Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A. Bioanalytical method validation--a revisit with a decade of progress. Pharm Res. 2000 Dec;17(12):1551-7. doi: 10.1023/a:1007669411738. No abstract available.

  PMID: 11303967 BACKGROUND

• Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res. 2007 Oct;24(10):1962-73. doi: 10.1007/s11095-007-9291-7. Epub 2007 Apr 26.

  PMID: 17458684 BACKGROUND

• King T, Bushman L, Anderson PL, Delahunty T, Ray M, Fletcher CV. Quantitation of zidovudine triphosphate concentrations from human peripheral blood mononuclear cells by anion exchange solid phase extraction and liquid chromatography-tandem mass spectroscopy; an indirect quantitation methodology. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Feb 2;831(1-2):248-57. doi: 10.1016/j.jchromb.2005.12.033. Epub 2006 Jan 10.

  PMID: 16412710 BACKGROUND

• Remmel RP, Kawle SP, Weller D, Fletcher CV. Simultaneous HPLC assay for quantification of indinavir, nelfinavir, ritonavir, and saquinavir in human plasma. Clin Chem. 2000 Jan;46(1):73-81.

  PMID: 10620574 BACKGROUND

Related Links

• University of Nebraska Medical Center HIV Clinic

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Uriel S Sandkovsky, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2010
• Primary Completion: April 30, 2011
• Study Completion: June 30, 2011
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

US (1)