Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002375
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter 24-Week Study of the Safety Pharmacokinetics and Activity of the Coadministration of Indinavir and Nelfinavir in HIV-1 Seropositive Patients
Status:
COMPLETED
Status Verified Date:
2000-02
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:
The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir IDV plus nelfinavir NFV 2 anti-HIV medications
It is thought that IDV plus NFV will be a safe drug combination for treating HIV
It is thought that IDV plus NFV will be a safe drug combination for treating HIV
Detailed Description:
It is hypothesized that the administration of indinavir with nelfinavir will be generally safe and well tolerated
This is a parallel time-lagged 2-stage multiple-dose 24-week study in HIV-1 seropositive patients In the 3-week randomized double-blind phase of Stage A patients receive either indinavir plus nelfinavir Group A1 9 patients or indinavir placebo plus nelfinavir placebo Group A2 3 patients for the first week In Week 2 patients in Group A1 have the nelfinavir dose increased This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity andor serious drug-related adverse events Patients in Group A2 continue to receive placebo until Week 3 at which time they receive indinavir plus nelfinavir initial dose while patients in Group A1 continue with indinavir plus nelfinavir escalated dose At Week 4 all patients in Stage A including those originally assigned to receive placebo receive open-label indinavir plus nelfinavir escalated dose for the remainder of the 24 weeks
After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability Stage B begins In the 2-week randomized double-blind phase of Stage B patients receive either indinavir plus nelfinavir Group B1 9 patients or indinavir placebo plus nelfinavir placebo Group B2 3 patients After 2 weeks all patients in Stage B including those originally assigned to receive placebo receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks
This is a parallel time-lagged 2-stage multiple-dose 24-week study in HIV-1 seropositive patients In the 3-week randomized double-blind phase of Stage A patients receive either indinavir plus nelfinavir Group A1 9 patients or indinavir placebo plus nelfinavir placebo Group A2 3 patients for the first week In Week 2 patients in Group A1 have the nelfinavir dose increased This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity andor serious drug-related adverse events Patients in Group A2 continue to receive placebo until Week 3 at which time they receive indinavir plus nelfinavir initial dose while patients in Group A1 continue with indinavir plus nelfinavir escalated dose At Week 4 all patients in Stage A including those originally assigned to receive placebo receive open-label indinavir plus nelfinavir escalated dose for the remainder of the 24 weeks
After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability Stage B begins In the 2-week randomized double-blind phase of Stage B patients receive either indinavir plus nelfinavir Group B1 9 patients or indinavir placebo plus nelfinavir placebo Group B2 3 patients After 2 weeks all patients in Stage B including those originally assigned to receive placebo receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 061-00 | None | None | None |
| MK-0639 | None | None | None |