Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002086
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir AZT and HIVID ddC Versus Retrovir HIVID and Wellferon Interferon Alfa-n1 for the Treatment of HIV Infection
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir AZT and HIVID ddC Versus Retrovir HIVID and Wellferon Interferon Alfa-n1 for the Treatment of HIV Infection
Status:
COMPLETED
Status Verified Date:
1993-10
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:
Primary To determine whether the combination of zidovudinezalcitabineinterferon alfa-n1 RetrovirHIVIDWellferon can produce complete responses ie CD4 counts return to 800 cellsmm3 for more than 24 weeks in patients with virus sensitive to all three agents To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only
Secondary To determine the effectiveness of RetrovirHIVID and RetrovirHIVIDWellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease To determine the effect of these regimens on secondary measures of clinical status eg performance score weight change and secondary infections and on measures of virologic activity such as serum p24 antigen To assess the safety and tolerance of these regimens
Secondary To determine the effectiveness of RetrovirHIVID and RetrovirHIVIDWellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease To determine the effect of these regimens on secondary measures of clinical status eg performance score weight change and secondary infections and on measures of virologic activity such as serum p24 antigen To assess the safety and tolerance of these regimens
Detailed Description:
None
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 |
|---|---|---|---|
| 03 | None | None | None |