Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001085
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Phase II Study of 141W94 VX-478 Monotherapy vs 141W94 VX-478 Plus ZDV Plus 3TC in HIV Infected Individuals
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To determine the proportion of patients whose plasma HIV-1 RNA level remains below a detectable level less than 500ml after 24 weeks of study therapy with either 141W94 monotherapy or 141W94 plus zidovudine ZDV and lamivudine 3TC To determine the safety and tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with HIV infection
Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability as has been observed with combinations of other protease inhibitors plus nucleoside analogs
Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability as has been observed with combinations of other protease inhibitors plus nucleoside analogs
Detailed Description:
Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability as has been observed with combinations of other protease inhibitors plus nucleoside analogs
In this randomized double-blind study patients HIV RNA is screened 30 days prior to entry Patients satisfying enrollment criteria must have been on a stable antiretroviral regimen for 30 days prior to study screening and remain on the same regimen until entry Patients are stratified based on the screening HIV-1 RNA copy number obtained within 30 days of entry 5000 - 50000 copiesml versus greater than 50000 copiesml In addition patients are stratified based on previous antiretroviral use naive versus experienced Patients are randomized to one of 2 treatment arms Arm A - 141W94 plus Zidovudine ZDV and Lamivudine 3TC or Arm B - 141W94 plus ZDV placebo and 3TC placebo
AS PER AMENDMENT 82597 Patients assigned to the monotherapy arm are advised to discontinue their study medication immediately and initiate antiretroviral therapy with indinavir nevirapine stavudine and 3TC as outlined in ACTG 347 roll-over protocol ACTG 373 Patients in the three-drug arm continue on study therapy AS PER AMENDMENT 121997 Patients receive study treatment for 56 weeks and are followed through week 68
In this randomized double-blind study patients HIV RNA is screened 30 days prior to entry Patients satisfying enrollment criteria must have been on a stable antiretroviral regimen for 30 days prior to study screening and remain on the same regimen until entry Patients are stratified based on the screening HIV-1 RNA copy number obtained within 30 days of entry 5000 - 50000 copiesml versus greater than 50000 copiesml In addition patients are stratified based on previous antiretroviral use naive versus experienced Patients are randomized to one of 2 treatment arms Arm A - 141W94 plus Zidovudine ZDV and Lamivudine 3TC or Arm B - 141W94 plus ZDV placebo and 3TC placebo
AS PER AMENDMENT 82597 Patients assigned to the monotherapy arm are advised to discontinue their study medication immediately and initiate antiretroviral therapy with indinavir nevirapine stavudine and 3TC as outlined in ACTG 347 roll-over protocol ACTG 373 Patients in the three-drug arm continue on study therapy AS PER AMENDMENT 121997 Patients receive study treatment for 56 weeks and are followed through week 68
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 |
|---|---|---|---|
| 11317 | REGISTRY | DAIDS ES | None |