Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002347
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection
Sponsor:
Parexel
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Master Protocol to Evaluate the Safety and Efficacy of Multi-Drug Combination Antiretroviral Therapy for the Treatment of HIV Infection RetrovirHIVIDNevirapine and RetrovirHIVIDInvirase
Status:
COMPLETED
Status Verified Date:
1995-06
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 evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection Specifically to evaluate zidovudinezalcitabine AZT ddC alone or in combination with either nevirapine or saquinavir Ro 31-8959
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available
Detailed Description:
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available
Patients are randomized to receive AZTddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks Patients are followed at weeks 2 and 4 and every 4 weeks thereafter
Patients are randomized to receive AZTddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks Patients are followed at weeks 2 and 4 and every 4 weeks thereafter
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 |
|---|---|---|---|
| ICC 001 | None | None | None |