Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002233
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of a Combination of Four Drugs in Patients With Recent HIV Infection
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II 48-Week Uncontrolled Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy EPIVIR Abacavir Amprenavir and Indinavir in Subjects Acutely Infected With HIV-1
Status:
COMPLETED
Status Verified Date:
1999-06
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:
The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also The four-drug combination includes lamivudine abacavir amprenavir and indinavir
Detailed Description:
Patients receive a four-drug regimen consisting of two nucleoside reverse transcriptase inhibitors 3TC and abacavir and two protease inhibitors amprenavir and indinavir for a minimum of 48 weeks At specified time points patients undergo physical assessments and efficacy evaluations which include plasma HIV-1 RNA measurements and CD4 cell counts Depending on the immunologic and virologic status of the patient further testing may be done to determine whether quadruple drug therapy can attain undetectable viral levels
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 |
|---|---|---|---|
| COLA 2012 | None | None | None |