Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001075
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine 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 Pilot Study to Evaluate the Immunologic Consequences of a Highly Active Antiretroviral Therapy Regimen HAART Consisting of Ritonavir ABT-538 Zidovudine AZT and Lamivudine 3TC in Moderately Advanced HIV-1 Disease
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 whether administration of a highly active antiretroviral treatment regimen consisting of ritonavir ABT-538 zidovudine AZT and lamivudine 3TC is associated with the restoration of delayed type hypersensitivity and lymphocyte proliferative responses in patients with moderately advanced HIV-1 infection To better characterize in these patients the phenotype of the expanded lymphocyte subpopulations as well as the genotype phenotype and cellular origin of viruses that persist after initiation of therapy and the genotype and phenotype of drug-resistant isolates that emerge during therapy
Although plasma viral load drops dramatically after initiation of powerful antiretrovirals it does not drop to zero It appears that a new steady state is reached suggesting that a reservoir may exist of virus-producing cells possibly cells of monocytemacrophage lineage that continue to produce a low level of virus despite antiretroviral treatment
Although plasma viral load drops dramatically after initiation of powerful antiretrovirals it does not drop to zero It appears that a new steady state is reached suggesting that a reservoir may exist of virus-producing cells possibly cells of monocytemacrophage lineage that continue to produce a low level of virus despite antiretroviral treatment
Detailed Description:
Although plasma viral load drops dramatically after initiation of powerful antiretrovirals it does not drop to zero It appears that a new steady state is reached suggesting that a reservoir may exist of virus-producing cells possibly cells of monocytemacrophage lineage that continue to produce a low level of virus despite antiretroviral treatment
Patients undergo 5 weeks of antiretroviral washout before initiating therapy with ritonavir alone for 9 days followed by combination therapy with ritonavir zidovudine and lamivudine from day 10 through week 48 AS PER AMENDMENT 13197 The availability of the current open-label study treatment has been extended to allow patients who have completed 48 weeks of therapy to continue protocol therapy until the last enrolled patient completes 48 weeks of study treatment
Patients undergo 5 weeks of antiretroviral washout before initiating therapy with ritonavir alone for 9 days followed by combination therapy with ritonavir zidovudine and lamivudine from day 10 through week 48 AS PER AMENDMENT 13197 The availability of the current open-label study treatment has been extended to allow patients who have completed 48 weeks of therapy to continue protocol therapy until the last enrolled patient completes 48 weeks of study treatment
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 |
|---|---|---|---|
| 10688 | REGISTRY | DAIDS ES | None |