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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00729924 |
This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CFS), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Raltegravir |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Parallel Assignment |
Official Title: | Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Raltegravir
400mg orally every 12 hours for 7 days
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The multidrug efflux transporter P-glycoprotein (P-gp) is expressed in the blood-brain barrier where it limits entry of substrate drugs into the central nervous system. Raltegravir (MK-0158), a new HIV-1 integrase inhibitor and potentially major addition to the therapeutic armamentarium against HIV, is a substrate for P-gp. Studies are warranted to elucidate the relevance of P-gp transport for raltegravir in the central nervous system.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Body mass index less than 30.
Body mass index = (weight in kilograms)/(height in meters)2 OR Body mass index = [(weight in pounds)/(height in inches)2] X 703
Estimated creatinine clearance ≥ 50 mL/minute within 30 days prior to study entry, calculated by the Cockcroft-Gault method as follows:
Men: creatinine clearance = [(140 - age) x (weight in kg)]/(72 x serum creatinine)
Women: creatinine clearance = 0.85 x [(140 - age) x (weight in kg)]/(72 x serum creatinine)
Laboratory values obtained within 30 days prior to study 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).
If participating in sexual activity that could lead to pregnancy, all study volunteers must agree that AT LEAST ONE of the following reliable methods of contraception will be used while they are receiving protocol-specified medications and for 6 weeks after stopping the medications:
IUD
NOTE: Use of hormonal contraceptives is prohibited during this study because of the potential for drug interactions.
All study volunteers who are not of reproductive potential (e.g., women who have been post-menopausal for at least 24 consecutive months, or women who have undergone surgical sterilization [e.g., hysterectomy and/or bilateral oophorectomy or salpingotomy], or men who have documented azoospermia) are eligible without requiring the use of contraception. Acceptable documentation of sterilization or menopause consists of written or oral documentation communicated by a clinician or a clinician's staff of one of the following:
Exclusion Criteria:
Contact: Deborah Sutherland, RN | 615-467-0154 ext 109 | deborah.sutherland@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt AIDS Clinical Trials Center | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Deborah Sutherland 615-467-0154 ext 109 deborah.sutherland@vanderbilt.edu | |
Principal Investigator: David W Haas, MD |
Principal Investigator: | David W Haas, MD | Vanderbilt University |
Responsible Party: | Vanderbilt Medical Center ( David W. Haas, MD ) |
Study ID Numbers: | 080536 |
Study First Received: | August 4, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00729924 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Raltegravir CSF ABCB1 SNP HIV/AIDS |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |