Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001766
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Drug Interactions Among Anti-HIV Agents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacokinetic Interactions Between Ritonavir Amprenavir and Efavirenz and Nelfinavir Amprenavir and Efavirenz in People Infected With HIV
Status:
COMPLETED
Status Verified Date:
2003-08
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 study examined the interactions of various drugs used to treat HIV infection in order to design larger studies of possible combinations for people who continue to have high viral levels despite combination therapy
HIV-infected patients 18 years of age and older who have a viral load of at least 500 copiesmL who have received 20 weeks of protease inhibitor therapy with the same protease inhibitors in combination therapy for the last 12 weeks and who have never been treated with abacavir amprenavir or efavirenz were enrolled
All patients will receive 600 milligrams a day of efavirenz a non-nucleoside reverse transcriptase inhibitor 300 mg twice daily of abacavir a nucleoside analog and 1200 mg twice a day of amprenavir a protease inhibitor In addition to these drugs six patients will receive 500 mg twice a day of ritonavir a protease inhibitor six patients will receive 200 mg twice a day of ritonavir and 10 will receive 1250 mg twice a day of nelfinavir a protease inhibitor
Patients in the two ritonavir groups 500-mg and 200-mg dose groups took abacavir and amprenavir for one week and then come to the clinic for blood tests to measure drug levels before taking their morning pills and at 12 1 2 4 8 and 12 hours after taking the medicines They will then add ritonavir to their treatment regimen After one week they will return for blood tests as before They will then add efavirenz to their regimen and had bloods drawn again after another 1 or 2 weeks
Patients in the nelfinavir group took abacavir amprenavir and nelfinavir for one week and then have blood sampling as described above for the ritonavir group They will then add efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks
Participants are being seen in the clinic for follow-up only if they wish to continue to participate and if the regimen appears to offer clinical benefit
HIV-infected patients 18 years of age and older who have a viral load of at least 500 copiesmL who have received 20 weeks of protease inhibitor therapy with the same protease inhibitors in combination therapy for the last 12 weeks and who have never been treated with abacavir amprenavir or efavirenz were enrolled
All patients will receive 600 milligrams a day of efavirenz a non-nucleoside reverse transcriptase inhibitor 300 mg twice daily of abacavir a nucleoside analog and 1200 mg twice a day of amprenavir a protease inhibitor In addition to these drugs six patients will receive 500 mg twice a day of ritonavir a protease inhibitor six patients will receive 200 mg twice a day of ritonavir and 10 will receive 1250 mg twice a day of nelfinavir a protease inhibitor
Patients in the two ritonavir groups 500-mg and 200-mg dose groups took abacavir and amprenavir for one week and then come to the clinic for blood tests to measure drug levels before taking their morning pills and at 12 1 2 4 8 and 12 hours after taking the medicines They will then add ritonavir to their treatment regimen After one week they will return for blood tests as before They will then add efavirenz to their regimen and had bloods drawn again after another 1 or 2 weeks
Patients in the nelfinavir group took abacavir amprenavir and nelfinavir for one week and then have blood sampling as described above for the ritonavir group They will then add efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks
Participants are being seen in the clinic for follow-up only if they wish to continue to participate and if the regimen appears to offer clinical benefit
Detailed Description:
In this study of pharmacokinetic interactions 1 the effect of ritonavir on the pharmacokinetics of amprenavir 2 the effect of efavirenz on the pharmacokinetics of amprenavir and ritonavir and 3 the effect of efavirenz on the pharmacokinetics of amprenavir and nelfinavir were examined Twenty-two patients who have a viral burden of at least 500 copiesmL on combination therapy with a protease inhibitor for at least 20 weeks were to be enrolled to receive open-label treatment 6 with abacavir 300 mg po BID amprenavir 1200 mg po BID ritonavir 200 mg po BID and efavirenz 600 mg po QD 6 with abacavir 300 mg po BID amprenavir 1200 mg po BID ritonavir 500 mg po BID and efavirenz 600 mg po QD and 10 with abacavir 300 mg po BID amprenavir 1200 mg po BID nelfinavir 1250 mg po BID and efavirenz 600 mg po QD The groups enrolled sequentially low-dose ritonavir combination group then the full dose ritonavir combination group and then the nelfinavir combination group Subjects were seen at pre-entry baseline Day 1 and thereafter at study weeks 1 serial sampling 2 serial sampling 4 8 12 16 24 then every 8 weeks through one year Patients discontinued current therapy and without a washout period began dosing For the groups who will receive ritonavir the schedule was dose with abacavir and amprenavir and after one-week serial plasma sampling was performed for baseline amprenavir levels Next ritonavir at the assigned dose was added for the full-dose there is a rapid dose escalation and plasma sampling was repeated one week later finally efavirenz 600 mg once daily will be added and plasma sampling was again be repeated between 2 weeks after beginning the combination For the nelfinavir group the schedule was dose with nelfinavir amprenavir and abacavir for one week and obtain serial plasma sampling then add efavirenz for another week and obtain serial plasma sampling Patients with a confirmed increase in viral burden of one log or greater from baseline will end study participation The safety and antiviral activity of each combination were also assessed and continue to be assessed toxicity management is outlined in the protocol This study remains open in order to continue to provide these drugs to subjects who completed the original one-year study period and who wish to continue medications that appear by viral load to be of benefit to them
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 |
|---|---|---|---|
| 98-I-0147 | None | None | None |