Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001010
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine Plus Acyclovir 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:
An Uncontrolled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Zidovudine AZT and Acyclovir ACV Given Concomitantly to 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 compare the effect of zidovudine AZT given alone with the combination of AZT and acyclovir ACV on the human immunodeficiency virus HIV in persons infected with HIV and to study the pharmacokinetics how fast AZT reaches certain levels in blood and how long it remains safety and effectiveness of AZT given alone and in combination with ACV in treating HIV-infected patients Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods and experiments in vitro in the test tube suggest that ACV may stimulate the action of AZT against HIV It is necessary to obtain information on how these drugs perform in HIV-infected humans
Detailed Description:
Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods and experiments in vitro in the test tube suggest that ACV may stimulate the action of AZT against HIV It is necessary to obtain information on how these drugs perform in HIV-infected humans
The first 12 patients will take AZT capsules every 4 hours and 6 of the patients will also take ACV 6 times a day Later groups of patients will receive higher doses of AZT if the earlier doses are tolerated without significant adverse effect It was initially planned to stop treatment after 12 weeks but if the first 10 patients who have entered the study have tolerated treatment well the duration of treatment will be extended with a crossover in dosage The treatment may be lifelong depending on the results obtained with regard to safety and effectiveness of the drugs Blood and urine samples will be obtained periodically in order to estimate blood levels of the drugs to study the excretion of the drugs and to determine the effects of the drugs on HIV and on the immune system and medical condition of the patient
The first 12 patients will take AZT capsules every 4 hours and 6 of the patients will also take ACV 6 times a day Later groups of patients will receive higher doses of AZT if the earlier doses are tolerated without significant adverse effect It was initially planned to stop treatment after 12 weeks but if the first 10 patients who have entered the study have tolerated treatment well the duration of treatment will be extended with a crossover in dosage The treatment may be lifelong depending on the results obtained with regard to safety and effectiveness of the drugs Blood and urine samples will be obtained periodically in order to estimate blood levels of the drugs to study the excretion of the drugs and to determine the effects of the drugs on HIV and on the immune system and medical condition of the patient
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 |
|---|---|---|---|
| 10986 | REGISTRY | DAIDS ES Registry Number | None |