Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000882
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
1999-11-02
Brief Title:
Virologic and Immunologic Activity of Continued Lamivudine 3TC vs Delavirdine DLV in Combination With Indinavir IDV and Zidovudine ZDV or Stavudine d4T in 3TC-Experienced Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Virologic and Immunologic Activity of Continued Lamivudine 3TC vs Delavirdine DLV in Combination With Indinavir IDV and Zidovudine ZDV or Stavudine d4T in 3TC-Experienced Subjects
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:
To compare the proportion of patients in the 2 zidovudine ZDV-containing arms who have a plasma HIV RNA concentration below the limit of detection defined as 500 copiesml or less at Weeks 20 and 24 AS PER AMENDMENT 82498 HIV RNA concentration below the limit of detection is now defined as 200 copiesml or less To compare the safety and tolerability of the different treatment regimens To compare the decrease in plasma HIV-1 RNA and the change in CD4 count from baseline to the average of Weeks 20 and 24 AS PER AMENDMENT 121997 and to the average of Weeks 44 and 48 AS PER AMENDMENT 82498 and the average of Weeks 88 and 96 in the 2 ZDV-containing arms To study the emergence of resistance to ZDV lamivudine 3TC stavudine d4T delavirdine DLV and indinavir IDV in treated patients To correlate the antiviral and immunologic activity and emergence of drug resistance with pharmacologic parameters of study drugs To delineate the pharmacokinetic interactions of IDV and DLV AS PER AMENDMENT 121997 To delineate the possible development of cellular resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on intracellular phosphorylation To document rates and patterns of adherence over the course of the study from day of randomization through 48 weeks AS PER AMENDMENT 82498 To define long-term durability of the virologic activity of the different treatment regimens as defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the limit of detection To define long-term tolerability of the different treatment regimens Although a change in reverse transcriptase RT inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen the choice of available RT inhibitors is often limited by prior exposure toxicity or pharmacologic interaction with the protease inhibitors This study addresses the question of whether to continue 3TC or substitute the nonnucleoside reverse transcriptase inhibitor NNRTI DLV when adding IDV to therapy for patients previously treated with ddI or d4T plus 3TC who have greater than 500 copiesml of plasma HIV-1 RNA Although the activity of DLV as monotherapy or in combination with nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of resistance it is possible that DLV will contribute significantly to the activity of 3-drug regimens that include a new RT inhibitor plus a protease inhibitor
Detailed Description:
Although a change in reverse transcriptase RT inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen the choice of available RT inhibitors is often limited by prior exposure toxicity or pharmacologic interaction with the protease inhibitors This study addresses the question of whether to continue 3TC or substitute the nonnucleoside reverse transcriptase inhibitor NNRTI DLV when adding IDV to therapy for patients previously treated with ddI or d4T plus 3TC who have greater than 500 copiesml of plasma HIV-1 RNA Although the activity of DLV as monotherapy or in combination with nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of resistance it is possible that DLV will contribute significantly to the activity of 3-drug regimens that include a new RT inhibitor plus a protease inhibitor
Patients with greater than 500 HIV-1 RNA copiesml are randomized to 3 treatment arms as follows
Arm I d4T ZDV placebo DLV IDV Arm II ZDV d4T placebo 3TC IDV Arm III ZDV d4T placebo DLV IDV Treatment on all arms is given for 24 weeks AS PER AMENDMENT 121997 The study is no longer partially blinded and placebo agents are no longer given treatment duration is now 48 weeks AS PER AMENDMENT 82498 study duration is now 96 weeks Rollover patients from ACTG 306 with greater than 500 HIV-1 RNA copiesml previously assigned to ZDV3TC are nonrandomly assigned to Arm I those previously assigned to ddI3TC or d4T3TC are randomized to Arm II or III Non-rollover patients are randomized to Arm II or III Rollover patients from ACTG 306 with 500 HIV-1copiesml or less continue on their previously assigned regimen AS PER AMENDMENT 121998 current regimen must be ZDV3TC ddI3TC or d4T3TC for the study duration or until an increase occurs If this increase occurs patients previously assigned to ZDV3TC are nonrandomly assigned to Arm I for the remaining study weeks while those previously assigned to either ddI3TC or d4T3TC are randomized to Arm II or III for the remaining study weeks Patients who received ddId4T or ddI3TC in ACTG 306 are stratified by whether patients received monotherapy or combination therapy during the first 24 weeks AS PER AMENDMENT 121997 48 weeks AS PER AMENDMENT 82498 96 weeks of ACTG 306
Patients with greater than 500 HIV-1 RNA copiesml are randomized to 3 treatment arms as follows
Arm I d4T ZDV placebo DLV IDV Arm II ZDV d4T placebo 3TC IDV Arm III ZDV d4T placebo DLV IDV Treatment on all arms is given for 24 weeks AS PER AMENDMENT 121997 The study is no longer partially blinded and placebo agents are no longer given treatment duration is now 48 weeks AS PER AMENDMENT 82498 study duration is now 96 weeks Rollover patients from ACTG 306 with greater than 500 HIV-1 RNA copiesml previously assigned to ZDV3TC are nonrandomly assigned to Arm I those previously assigned to ddI3TC or d4T3TC are randomized to Arm II or III Non-rollover patients are randomized to Arm II or III Rollover patients from ACTG 306 with 500 HIV-1copiesml or less continue on their previously assigned regimen AS PER AMENDMENT 121998 current regimen must be ZDV3TC ddI3TC or d4T3TC for the study duration or until an increase occurs If this increase occurs patients previously assigned to ZDV3TC are nonrandomly assigned to Arm I for the remaining study weeks while those previously assigned to either ddI3TC or d4T3TC are randomized to Arm II or III for the remaining study weeks Patients who received ddId4T or ddI3TC in ACTG 306 are stratified by whether patients received monotherapy or combination therapy during the first 24 weeks AS PER AMENDMENT 121997 48 weeks AS PER AMENDMENT 82498 96 weeks of ACTG 306
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 |
|---|---|---|---|
| 11332 | REGISTRY | DAIDS-ES | None |