Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000997
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Dideoxycytidine in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection
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 how much of a dose is absorbed by the body when zalcitabine dideoxycytidine ddC is given orally and how long the drug stays in the body after absorption or intravenous IV administration
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes The study will reveal the pharmacokinetic blood levels properties of this new drug and how long the drug remains in the body at each of six doses This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation such as a tablet or capsule since dose-related problems will already be known
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes The study will reveal the pharmacokinetic blood levels properties of this new drug and how long the drug remains in the body at each of six doses This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation such as a tablet or capsule since dose-related problems will already be known
Detailed Description:
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes The study will reveal the pharmacokinetic blood levels properties of this new drug and how long the drug remains in the body at each of six doses This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation such as a tablet or capsule since dose-related problems will already be known
Patients are hospitalized and receive ddC twice once by mouth and once by IV injection Each patient receives the drug at one of six increasing doses and no patient is studied at more than one dose level Following each dose toxicity is measured before the next higher dose is given Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body
Patients are hospitalized and receive ddC twice once by mouth and once by IV injection Each patient receives the drug at one of six increasing doses and no patient is studied at more than one dose level Following each dose toxicity is measured before the next higher dose is given Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body
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 |
|---|---|---|---|
| 10987 | REGISTRY | DAIDS ES Registry Number | None |