Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002396
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study of the Safety Tolerance Pharmacokinetics and Antiviral Activity of 9-2-R-BisIsopropoxycarbonyl- OxyMethoxyPhosphinoylMethoxyPropylAdenine Fumarate PMPA Prodrug in HIV-Infected Patients
Status:
UNKNOWN
Status Verified Date:
1999-11
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:
To evaluate the safety of single and multiple doses 28 daily doses of 9-2-R-bisisopropoxycarbonyl- oxymethoxyphosphinoylmethoxypropyladenine fumarate PMPA prodrug administered orally to HIV-infected patients To determine the pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to HIV-infected patients To evaluate the anti-HIV activity of PMPA prodrug as demonstrated by increases in CD4 cell counts and decreases in HIV RNA when administered orally as a single dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more cellsmm3
Detailed Description:
In this double-blind placebo-controlled study a total of 60 patients are randomized to receive PMPA prodrug at 1 of 5 doses or matching placebo tablets
Part A Days 1-7 Patients receive a single dose of PMPA prodrug or matching placebo tablets administered orally followed by a 1-week observation period Patients who complete Part A without a dose-limiting toxicity begin Part B
Part B Days 8-35 Patients receive either PMPA prodrug or matching placebo tablets administered orally qd for 4 weeks at the same dosage level administered in Part A
Part A Days 1-7 Patients receive a single dose of PMPA prodrug or matching placebo tablets administered orally followed by a 1-week observation period Patients who complete Part A without a dose-limiting toxicity begin Part B
Part B Days 8-35 Patients receive either PMPA prodrug or matching placebo tablets administered orally qd for 4 weeks at the same dosage level administered in Part A
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 |
|---|---|---|---|
| GS-97-901 | None | None | None |