Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States

Completed · Phase 4

Conditions studied: HIV Infection

In brief

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 Blood will be withdrawn according to the following schedule: * About 5 tablespoons will be collected upon arrival at the clinic after an overnight fast.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. ...

Key facts

Study ID

NCT00054743

Run by

National Institutes of Health Clinical Center (CC)

People needed

24

Starts

2003-02-06

Expected to finish

2011-04-28

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Joint Clinical Research Center (JCRC) — Kampala, Uganda

Full record on ClinicalTrials.gov

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