Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006154
Status:
COMPLETED
Last Update Posted:
2013-09-06
First Post:
2000-08-07
Brief Title:
A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 IL-2 in the Treatment of Early HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Controlled Open Label Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen d4TddIIDVRTV Versus a Protease-Sparing Regimen d4TddIEFV and the Ability of Interleukin-2 to Purge HIV From Latent Stores in Patients With AcuteEarly HIV Infection
Status:
COMPLETED
Status Verified Date:
2013-09
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 look at the effectiveness of combination anti-HIV drug therapy with protease inhibitors PIs or without in patients with early HIV infections This study also looks at whether a drug called interleukin-2 IL-2 can boost the immune system of these patients
Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment PIs are anti-HIV drugs that decrease viral load level of HIV in the blood However PIs can cause serious side effects in some patients Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs
Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment PIs are anti-HIV drugs that decrease viral load level of HIV in the blood However PIs can cause serious side effects in some patients Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs
Detailed Description:
Studies have suggested that an antiretroviral drug regimen of the non-nucleoside agent efavirenz EFV in combination with two nucleoside analogues is effective at achieving maximal viral suppression This provides an alternative treatment to that of the more toxic PI-containing regimen This trial examines whether a nonPI regimen with EFV is more beneficial than a PI-containing regimen when each is used in combination with the same two nucleoside analogues A second part of the study looks at whether the addition of IL-2 may offer immunologic benefits as a co-administered drug
Patients are randomized to initiate antiretroviral therapy of a PI-based stavudinedidanosineritonavir RTVindinavir IDV or nonPI-based stavudinedidanosineEFV regimen Within these treatment arms they are stratified according to a positive or negative p24 antigen result At Week 16 patients not achieving maximal viral suppression lower than 50 copiesml have the option to add abacavir ABC or other drugs as intensification therapy Those achieving virologic suppression less than 50 copiesml are randomized either to receive IL-2 or not At study entry and after 12 months tissue samples of CSF lymph node and genital secretions are obtained with permission Patients have physical exams women of child-bearing potential have pregnancy tests and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed Compensation for time and transportation is given
Patients are randomized to initiate antiretroviral therapy of a PI-based stavudinedidanosineritonavir RTVindinavir IDV or nonPI-based stavudinedidanosineEFV regimen Within these treatment arms they are stratified according to a positive or negative p24 antigen result At Week 16 patients not achieving maximal viral suppression lower than 50 copiesml have the option to add abacavir ABC or other drugs as intensification therapy Those achieving virologic suppression less than 50 copiesml are randomized either to receive IL-2 or not At study entry and after 12 months tissue samples of CSF lymph node and genital secretions are obtained with permission Patients have physical exams women of child-bearing potential have pregnancy tests and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed Compensation for time and transportation is given
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTN 124 | None | None | None |
| 11530 | REGISTRY | DAIDS-ES | None |