Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000740
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To determine the maximum tolerated dose MTD of WR 6026 in HIV-infected patients To determine whether any unexpected toxicities are caused by WR 6026 in HIV-infected patients To determine whether there is additional toxicity when WR 6026 is given for 21 days rather than 14 days To further investigate the pharmacokinetics and pharmacodynamics of WR 6026 and in particular to examine potential correlations between the area under the concentration-time curve and methemoglobinemia or other toxicities
In recent animal studies WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia PCP This study will assess the safety and tolerance of this drug in HIV-infected patients who do not have PCP
In recent animal studies WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia PCP This study will assess the safety and tolerance of this drug in HIV-infected patients who do not have PCP
Detailed Description:
In recent animal studies WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia PCP This study will assess the safety and tolerance of this drug in HIV-infected patients who do not have PCP
Escalating doses of WR 6026 will be studied in successive patient cohorts Four patients will be randomized to active drug or placebo in a 31 ratio at each dose level until moderate toxicity is demonstrated If one patient at a given dose level experiences WR 6026-related moderate or worse toxicity the sample size for all subsequent dose levels will be doubled If two or more patients at a given dose level experience moderate or dose-limiting toxicity an additional four patients randomized in the same 31 ratio will be entered at that level and sample size at all subsequent dose levels will be doubled Dose escalation will continue until three of six patients receiving active drug at a given dose level experience dose-limiting or worse toxicity or until two of six patients at a given dose level experience life-threatening toxicity The MTD will be defined as the dose immediately below the highest dose studied Eight additional patients will be studied at the presumed MTD to confirm tolerance
Escalating doses of WR 6026 will be studied in successive patient cohorts Four patients will be randomized to active drug or placebo in a 31 ratio at each dose level until moderate toxicity is demonstrated If one patient at a given dose level experiences WR 6026-related moderate or worse toxicity the sample size for all subsequent dose levels will be doubled If two or more patients at a given dose level experience moderate or dose-limiting toxicity an additional four patients randomized in the same 31 ratio will be entered at that level and sample size at all subsequent dose levels will be doubled Dose escalation will continue until three of six patients receiving active drug at a given dose level experience dose-limiting or worse toxicity or until two of six patients at a given dose level experience life-threatening toxicity The MTD will be defined as the dose immediately below the highest dose studied Eight additional patients will be studied at the presumed MTD to confirm tolerance
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 |
|---|---|---|---|
| 11148 | REGISTRY | DAIDS ES Registry Number | None |