Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084149
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2004-06-07
Brief Title:
Cyclosporine A in Combination With Abacavir Sulfate Lamivudine and Zidovudine and LopinavirRitonavir in HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Study of the Safety Immunologic and Virologic Effects of Cyclosporine A in Conjunction With TrizivirR and KaletraR Versus TrizivirR and KaletraR Alone During Primary HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2018-08
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:
Cyclosporine A CsA is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs CsA may also help people with HIV The purpose of this study is to determine the safety of and immune response to CsA when given with abacavir sulfate ABC lamivudine 3TC and zidovudine AZT ABC3TCAZT and lopinavirritonavir LPVr to HIV infected adults in the early stages of infection
Study hypothesis The combination of CsA and LPVr given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPVr alone
Study hypothesis The combination of CsA and LPVr given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPVr alone
Detailed Description:
During the early stages of HIV infection HIV replicates unchecked massive numbers of cluster of differentiation 4 CD4 T cells are infected and destroyed and other CD4 cells become infected but enter a latent phase This latent pool of infected CD4 cells poses a difficult challenge in eliminating HIV infection during the early stages of infection because the cells persist for long periods even with highly active effective antiretroviral therapy and may later become active
CsA is popularly used as a lifelong immunosuppressant for organ transplant patients CsA inhibits cellular activation including CD4 cell activation and proliferation By reducing CD4 cell activation during acute HIV infection fewer CD4 cells may be infected and die more importantly there may be fewer latent cells with the potential to become active later in the disease However CsA has many potential toxic effects including renal damage and may affect neurologic endocrine and hepatic organ systems
In a previous small study of adults with acute HIV infection a short 8-week course of CsA was well tolerated and it is thought that a 4-week course of CsA may result in substantial reduction in both viral load and T cell activation outweighing any potential toxic effects sustained during the one month treatment This study will evaluate the safety of and immune response to a 4-week course of CsA with ABC3TCAZT and LPVr compared to ABC3TCAZT and LPVr alone in patients with acute HIV infection
This 48-week study will randomly assign patients to one of two arms During the first 4 weeks of the study Arm A will receive one tablet of ABC3TCAZT twice daily 3 capsules or 2 tablets of LPVr twice daily and liquid CsA dose determined by weight twice daily At Week 5 Arm A patients will stop CsA but continue both ABC3TCAZT and LPVr Arm B will receive one tablet of ABC3TCAZT twice daily and 3 capsules or 2 tablets of LPVr twice daily for all 48 weeks On a case-by-case basis an investigator may wish to prescribe ABC3TC rather than ABC3TCAZT at initial therapy Participants with ABC hypersensitivity will be given 3TCAZT instead of ABC3TCAZT
A complete physical exam and medical history assessment will occur at study entry and at Week 48 Study visits will occur every week until Week 4 then every 4 weeks until the end of the study Blood and urine collection and clinical assessments will occur at each study visit Additionally patients in Arm A only will undergo CsA level monitoring at Day 3 and Weeks 1 2 and 3 CsA dosage may be adjusted as necessary
CsA is popularly used as a lifelong immunosuppressant for organ transplant patients CsA inhibits cellular activation including CD4 cell activation and proliferation By reducing CD4 cell activation during acute HIV infection fewer CD4 cells may be infected and die more importantly there may be fewer latent cells with the potential to become active later in the disease However CsA has many potential toxic effects including renal damage and may affect neurologic endocrine and hepatic organ systems
In a previous small study of adults with acute HIV infection a short 8-week course of CsA was well tolerated and it is thought that a 4-week course of CsA may result in substantial reduction in both viral load and T cell activation outweighing any potential toxic effects sustained during the one month treatment This study will evaluate the safety of and immune response to a 4-week course of CsA with ABC3TCAZT and LPVr compared to ABC3TCAZT and LPVr alone in patients with acute HIV infection
This 48-week study will randomly assign patients to one of two arms During the first 4 weeks of the study Arm A will receive one tablet of ABC3TCAZT twice daily 3 capsules or 2 tablets of LPVr twice daily and liquid CsA dose determined by weight twice daily At Week 5 Arm A patients will stop CsA but continue both ABC3TCAZT and LPVr Arm B will receive one tablet of ABC3TCAZT twice daily and 3 capsules or 2 tablets of LPVr twice daily for all 48 weeks On a case-by-case basis an investigator may wish to prescribe ABC3TC rather than ABC3TCAZT at initial therapy Participants with ABC hypersensitivity will be given 3TCAZT instead of ABC3TCAZT
A complete physical exam and medical history assessment will occur at study entry and at Week 48 Study visits will occur every week until Week 4 then every 4 weeks until the end of the study Blood and urine collection and clinical assessments will occur at each study visit Additionally patients in Arm A only will undergo CsA level monitoring at Day 3 and Weeks 1 2 and 3 CsA dosage may be adjusted as necessary
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 |
|---|---|---|---|
| 10023 | REGISTRY | DAIDS ES | None |