NCT00054743

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

Completed Phase 4 Last updated 2 July 2017

What this trial tests

Phase 4 trial testing Blood draw in HIV Infection in 24 participants. Completed in 28 April 2011.

Timeline

6 February 2003

28 April 2011

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	24
Start date	6 February 2003
Estimated completion	28 April 2011
Sites	2 locations across United States, Uganda

Drugs / interventions tested

• Blood draw — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

18 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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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Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.