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
2 other identifiers
interventional
24
2 countries
2
Brief Summary
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 Blood will be withdrawn according to the following schedule: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. ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2003
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2003
CompletedFirst Submitted
Initial submission to the registry
February 7, 2003
CompletedFirst Posted
Study publicly available on registry
February 10, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2011
CompletedJuly 2, 2017
April 28, 2011
February 7, 2003
June 30, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Joint Clinical Research Center (JCRC)
Kampala, Uganda
Related Publications (3)
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.
PMID: 7477167BACKGROUNDHarris 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.
PMID: 9607828BACKGROUNDHoetelmans 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.
PMID: 9708400BACKGROUND