- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00054743
Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States
Global Initiative to Characterize Differences in Antiretroviral Pharmacokinetics in HIV-Infected Populations
This study will determine whether blood levels of the anti-HIV medicine nevirapine are different in HIV-infected patients in the United States from patients in Uganda. People from all over the world take medications to treat HIV infection. These medicines work well in some people but not in others, and they cause harmful side effects in some people and not in others. These differences may be related to variations in how much of the drug reaches the blood. Differences in drug blood levels among people in various areas of the world may be attributed to differences in diet, state of health, ability to absorb the medicines from the stomach, ability to eliminate the drugs from the body, and the brand of medicine taken. This study will help scientists learn whether differences in blood levels of HIV medicines are important in determining how well the drugs work in different patient populations.
HIV-infected patients 18 years of age and older in the United States and in Kampala, Uganda who have been on an antiretroviral treatment regimen that includes at least 28 consecutive days of nevirapine may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests.
Participants will have a total of approximately about 5 ounces of blood drawn during this 6- to 8-hour study. They will come to the NIH clinic in the morning, and a catheter (plastic tube) will be inserted into an arm vein for collecting blood. (Alternatively, blood can be collected by a needle inserted into an arm vein.) Blood will be withdrawn according to the following schedule:
- About 5 tablespoons will be collected upon arrival at the clinic after an overnight fast. Within 30 minutes of this blood draw, the patient will have breakfast and take his or her morning dose of nevirapine, along with any other medications that need to be taken at that time.
- 1 tablespoon of blood will be drawn 2 hours after the nevirapine dose.
- 1 tablespoon of blood will be drawn 4 hours later (6 hours after the nevirapine dose).
The blood will be analyzed for levels of nevirapine and possibly other HIV medicines. Some of the blood will be stored for later analysis of genes (cytochrome P450 and MDR1) that are involved in eliminating medicines from the body.
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Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Kampala, Uganda
- Joint Clinical Research Center (JCRC)
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Documentation in the patient's medical record of HIV-1 infection using double ELISA or a second confirmatory test (e.g., Western Blot) or any one of the following: detectable p24 antigen, quantifiable plasma HIV RNA, or detectable proviral DNA.
- Males and females greater than or equal to 18 years of age
Laboratory values within acceptable limits
AST/SGOT less than or equal to 5 times the upper limit of normal (ULN)
Serum creatinine less than or equal to 2 times the ULN
Hemoglobin greater than or equal to 9.0 g/dL
- Receipt of a stable nevirapine-containing antiretroviral regimen for at least 28 days.
- Informed consent signed and subject declares that they have been adherent to their nevirapine-containing antiretroviral regimen.
EXCLUSION CRITERIA:
- Presence of life-threatening or unstable renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric, or respiratory disease, as determined by medical records, or any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigator.
Laboratory values outside acceptable limits
AST/SGOT less than 5 times the upper limit of normal (ULN)
Serum creatinine greater than 2 times the ULN
Hemoglobin less than 9.0 g/dL
- Positive pregnancy test.
- Receipt of IL-2 within 3 months of study participation.
- Drug or alcohol use that may impair safety or adherence.
- Poor venous access.
- Documented or reported fever (greater than 38.5 degrees C) within 7 days of screening.
- Active opportunistic infection requiring therapy.
- Refusal to agree to allow for specimens to be stored for future research.
- Greater than 4 loose/soft stools per day.
- Subject is non-adherent with their nevirapine-containing antiretroviral regimen and/or they have not provided informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Publications and helpful links
General Publications
- Danner SA, Carr A, Leonard JM, Lehman LM, Gudiol F, Gonzales J, Raventos A, Rubio R, Bouza E, Pintado V, et al. A short-term study of the safety, pharmacokinetics, and efficacy of ritonavir, an inhibitor of HIV-1 protease. European-Australian Collaborative Ritonavir Study Group. N Engl J Med. 1995 Dec 7;333(23):1528-33. doi: 10.1056/NEJM199512073332303.
- Harris M, Durakovic C, Rae S, Raboud J, Fransen S, Shillington A, Conway B, Montaner JS. A pilot study of nevirapine, indinavir, and lamivudine among patients with advanced human immunodeficiency virus disease who have had failure of combination nucleoside therapy. J Infect Dis. 1998 Jun;177(6):1514-20. doi: 10.1086/515317.
- Hoetelmans RM, Reijers MH, Weverling GJ, ten Kate RW, Wit FW, Mulder JW, Weigel HM, Frissen PH, Roos M, Jurriaans S, Schuitemaker H, de Wolf F, Beijnen JH, Lange JM. The effect of plasma drug concentrations on HIV-1 clearance rate during quadruple drug therapy. AIDS. 1998 Jul 30;12(11):F111-5. doi: 10.1097/00002030-199811000-00002.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030091
- 03-CC-0091
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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