Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014937
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2001-04-14
Brief Title:
Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Controlled Trial of Two Potent Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copiesml
Status:
COMPLETED
Status Verified Date:
2013-07
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:
ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood The study will also evaluate whether patients discontinue the regimens because of drug side effects
Detailed Description:
ACTG 388 was designed to evaluate two four-drug regimens compared with a three-drug regimen in patients who were relatively treatment naive Based on the increased complexity and toxicity of four-drug regimens and the resultant negative impact on response as compared with three-drug regimens studies evaluating simplified potent regimens appear warranted This study will evaluate simpilified drug regimens designed to enhance virologic activity without necessarily increasing the number of antiretroviral drugs The study regimens will be assessed for both virologic control and tolerability The study population will include patients previously enrolled in ACTG 388 and patients with prior advanced HIV disease who received and responded to potent antiretroviral therapy without evidence of virologic relapse
Patients will be stratified according to ACTG 388 treatment or non-ACTG 388 study participation Patients will then be randomized to receive either a protease inhibitor PI-sparing regimen of 2 nucleoside reverse transcriptase inhibitors NRTIs with efavirenz EFV Arm I or an NRTI-sparing regimen of EFV with lopinavirritonavir LPVr Arm II Arm I options are enteric-coated didanosine ddI-EC plus lamivudine 3TC ddI-EC plus zidovudine ZDV ZDV plus 3TC or Combivir stavudine d4T plus 3TC or ddI-EC plus d4T with exceptions as noted in the protocol Only LPVr EFV d4T and ddI are provided by the study other medications are obtained by nonstudy prescription
All patients are evaluated for safety and for virologic and immunologic responses at Weeks 4 and 8 then every 8 weeks until the study ends In addition all patients have assessments for fat redistribution fasting lipid profiles fasting insulin levels venous lactate levels and treatment adherence Patients will be followed for 15 to 3 years Interim safety analyses will be conducted in June 2002 and June 2003 Patients in this study may also enroll in A5125s a fat distribution and bone mineral density substudy
Patients will be stratified according to ACTG 388 treatment or non-ACTG 388 study participation Patients will then be randomized to receive either a protease inhibitor PI-sparing regimen of 2 nucleoside reverse transcriptase inhibitors NRTIs with efavirenz EFV Arm I or an NRTI-sparing regimen of EFV with lopinavirritonavir LPVr Arm II Arm I options are enteric-coated didanosine ddI-EC plus lamivudine 3TC ddI-EC plus zidovudine ZDV ZDV plus 3TC or Combivir stavudine d4T plus 3TC or ddI-EC plus d4T with exceptions as noted in the protocol Only LPVr EFV d4T and ddI are provided by the study other medications are obtained by nonstudy prescription
All patients are evaluated for safety and for virologic and immunologic responses at Weeks 4 and 8 then every 8 weeks until the study ends In addition all patients have assessments for fat redistribution fasting lipid profiles fasting insulin levels venous lactate levels and treatment adherence Patients will be followed for 15 to 3 years Interim safety analyses will be conducted in June 2002 and June 2003 Patients in this study may also enroll in A5125s a fat distribution and bone mineral density substudy
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 |
|---|---|---|---|
| 10934 | REGISTRY | DAIDS-ES | None |
| AACTG 5116 | None | None | None |
| Substudy AACTG A5124s | None | None | None |
| Substudy AACTG A5125s | None | None | None |
| ACTG A5116 | None | None | None |