Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002243
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor NNRTI -Calanolide A in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment
Sponsor:
Sarawak MediChem Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase 1B Dose-Range Study to Evaluate the Safety Pharmacokinetics and Effects of -Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2000-07
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 test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor NNRTI -calanolide A in HIV-positive patients who have never received anti-HIV treatment
Detailed Description:
Patients are randomized into 2 cohorts with Cohort 2 receiving a higher dosage than Cohort 1 Patients in each cohort receive either -calanolide A or a placebo for 14 days followed by a 14-day follow-up period Following study treatment patients may elect to receive an open-label 6-month course of anti-HIV drugs to be selected by and administered under the care of the patients physician
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-9802 | None | None | None |