Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005120
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-20
Brief Title:
The Safety and Effectiveness of -Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
Sarawak MediChem Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IB Study to Evaluate the Safety Pharmacokinetics and Effects of -Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past
Detailed Description:
Patients are randomized to receive -calanolide A or placebo for 21 days All patients may elect to receive an open-label 3-month course of approved retroviral therapy up to triple-drug therapy to be selected by and administered under the care of the patients physicians If the patient has no insurance coverage or does not wish to utilize hisher insurance for anti-HIV medications Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months
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 |
|---|---|---|---|
| 57CL-0001 | None | None | None |