Viewing Study NCT00005673



Ignite Creation Date: 2024-05-05 @ 9:57 AM
Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005673
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2000-05-24

Brief Title: Safety and Anti-HIV Activity of Capravirine Alone and in Combination With Other Anti-HIV Drugs
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Safety and Pharmacokinetic Study of Capravirine Part I Pharmacokinetics of Capravirine in HIV-Negative Volunteers Part II Antiviral Activity of Capravirine Efavirenz and Abacavir in HIV-Infected Patients
Status: COMPLETED
Status Verified Date: 2002-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This 2-part study will test the safety and anti-HIV activity of capravirine alone and the safety anti-HIV activity and drug interactions of capravirine combined with other anti-HIV drugs Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors NNRTIs which are effective when used together with other drugs including nucleoside reverse transcriptase inhibitors NRTIs and protease inhibitors

Normal volunteers 18 years of age and older may enroll in Part 1 of the study HIV-infected patients 18 years of age and older who have not previously been treated with a NNRTI efavirenz nevirapine and delavirdine may participate in Part 2 All prospective study participants will be screened for eligibility with a physical examination blood tests a urine test and an electrocardiogram ECG

Part 1 - Volunteers will be randomly assigned to one of two treatment groups as follows

Group 1 will receive capravirine alone for 7 days and capravirine plus efavirenz another NNRTI for an additional 10 days On day 1 participants will have a physical examination urine test and laboratory blood tests Blood samples will be collected just before the first dose of capravirine is given and again at 05 1 2 4 6 8 and 12 hours after the dose A small plastic tube will be placed in a vein to avoid multiple needle sticks On day 8 participants will have another physical examination and laboratory blood tests Blood samples will be drawn again as described above In the evening of day 8 efavirenz will be added to the regimen On day 18 the last day of the study participants will have another physical examination and blood tests Blood will again be collected as described above

Group 2 will take capravirine alone for 8 days and capravirine plus ritonavir a protease inhibitor for an additional 8 days Physical examinations urine tests and blood collections will be done as described above on day 1 day 8 and day 16 the last day of the study

Part 2 - Patients will take capravirine alone for 7 days On day 1 patients will have a physical examination urine test and laboratory blood tests Blood samples will be collected just before the first dose of capravirine is given and again at 05 1 2 4 6 8 and 12 hours after the dose A small plastic tube will be placed in a vein to avoid multiple needle sticks On day 8 patients will have another physical examination and laboratory blood tests Blood samples will be drawn again as described above Additional drugs will then be added to the regimen in varying doses according to group as follows

Group 1 - efavirenz plus abacavir

Group 2 - ritonavir plus efavirenz plus abacavir

Group 3 - ritonavir plus efavirenz plus abacavir

On day 15 the procedures performed on day 8 will be repeated

Patients will have the option of having blood drawn daily on days 2 through 7 to measure HIV-1 viral load and of having a lumbar puncture spinal tap done between days 2 and 7 to measure how well capravirine gets into the central nervous system

After day 15 patients in all groups will continue with their drug regimen until week 48 or until it is determined that the treatment is not effective for the patient Physical examinations viral load measurements white blood cell counts and other blood tests will be done periodically throughout the trial Within 4 weeks after the end of the study patients will be followed with another physical examination blood and urine tests and an ECG
Detailed Description: This is an open-label phase I study examining the safety and anti-HIV activity of an investigational non-nucleoside reverse transcriptase inhibitor capravirine The primary objectives of the study are 1 To evaluate the safety and pharmacokinetics of capravirine when combined with efavirenz and low-dose ritonavir in non-HIV-infected volunteers 2 To evaluate the safety virologic activity and pharmacokinetics of capravirine when combined with efavirenz low-dose ritonavir and abacavir in HIV-infected patients and 3 To evaluate the safety virologic activity and pharmacokinetics of a once-daily regimen with capravirine efavirenz low-dose ritonavir and abacavir in HIV-infected patients The study will be conducted in 2 parts Part I will examine the safety pharmacokinetics and potential drug interactions of capravirine with other antiretroviral agents in non-HIV-infected volunteers Sixteen volunteers 8 per group will receive capravirine monotherapy 7 days followed by the addition of either 1 efavirenz 10 days or 2 ritonavir 8 days Part II will examine the safety virologic activity pharmacokinetics and potential drug interactions of capravirine in HIV-infected patients Thirty patients 10 per group will receive of capravirine monotherapy 7 days followed by the randomized addition of 1 efavirenzabacavir 7 days 2 ritonavirefavirenzabacavir 7 days twice-daily regimen or 3 ritonavirefavirenzabacavir 7 days once-daily regimen Doses of capravirine may be changed depending upon pharmacokinetic data obtained from Part I of the study The primary efficacy endpoint is the time-to-virologic-failure

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
00-I-0129 None None None