Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034086
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2002-04-22
Brief Title:
Study of Anti-HIV Therapy Intensification
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immunologic Consequences of Antiretroviral Therapy Intensification in Subjects With Moderately Advanced HIV-1 Disease A Follow-Up Study to ACTG 315375
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see how the bodys immune system changes after replacing and adding new anti-HIV drugs to a patients current anti-HIV therapy This study will also see whether adding drugs is safe Patients who take part in A5136 are also eligible to take part in 2 substudies The purpose of substudy A5140s is to see how many latently infected cells cells in which the HIV virus survives are in the lymph node small rounded structures that make disease-fighting cells Substudy A5155s will be performed to see how many latently infected cells are in the blood before and after replacing and adding anti-HIV drugs
ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375 which were designed to examine the effects of highly active antiretroviral therapy HAART in certain HIV-infected patients Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus suppressed However most of these patients still have problems with their immune systems The reason for these problems is unknown This study may help researchers understand what causes immune system problems in people who have low levels of HIV in their blood
ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375 which were designed to examine the effects of highly active antiretroviral therapy HAART in certain HIV-infected patients Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus suppressed However most of these patients still have problems with their immune systems The reason for these problems is unknown This study may help researchers understand what causes immune system problems in people who have low levels of HIV in their blood
Detailed Description:
ACTG 315 and its follow-up study ACTG 375 were designed to examine the immunologic and virologic consequences of highly active antiretroviral therapy HAART in patients with moderately advanced HIV-1 disease At the conclusion of ACTG 375 patients eligible for participation in ACTG A5136 will have received over 5 years of antiretroviral therapy Despite long-term therapy and long-term maximal viral suppression in most patients significant immune defects such as impaired response to antigens including HIV abnormally low CD4 cell counts abnormally high immune activation and decreased expression of CD28 persist It is uncertain whether these defects persist as a result of irreversible damage inflicted by HIV infection or ongoing immune perturbation resulting from continuous low-level HIV replication Cellular reservoirs of HIV that persist despite undetectable plasma viral load may contribute to persistent immune activation and impaired immune function A great deal of information on the relationship between low-level viral replication and persistent immune impairment may be gained by investigating these patients before and after intensification of their antiretroviral therapy regimens
Patients continue to receive their ACTG 375 antiretroviral therapy until they register to A5136 Following entry evaluations patients replace the protease inhibitors PIs in their ACTG 375 regimen with lopinavirritonavir LPVr add tenofovir disoproxil fumarate TDF to their regimen and maintain the rest of their ACTG 375 regimen for 48 weeks Patients have clinic visits at entry and at Weeks 4 12 and 16 After 24 weeks patients have clinic visits every 12 weeks Blood is drawn at these visits for viral load immune response and other routine tests A skin test a urine sample collection and a pregnancy test for women of reproductive potential are also performed at entry Patients also receive immunizations At Weeks 12 and 16 a lyme vaccine polyvalent is administered At Week 36 lyme vaccine polyvalent pneumococcal vaccine polyvalent and haemophilus b conjugate HIB vaccine are administered AS PER AMENDMENT 051402 Lyme disease vaccine has been removed from the study due to unavailability At Week 48 skin tests are performed Week 52 is the final clinic visit at which blood is drawn and a urine sample is taken
Patients who participate in substudy A5140s undergo 2 lymph node aspirates at entry and at Week 48 Patients participating in substudy A5155s have blood drawn at screening and Week 48
Patients continue to receive their ACTG 375 antiretroviral therapy until they register to A5136 Following entry evaluations patients replace the protease inhibitors PIs in their ACTG 375 regimen with lopinavirritonavir LPVr add tenofovir disoproxil fumarate TDF to their regimen and maintain the rest of their ACTG 375 regimen for 48 weeks Patients have clinic visits at entry and at Weeks 4 12 and 16 After 24 weeks patients have clinic visits every 12 weeks Blood is drawn at these visits for viral load immune response and other routine tests A skin test a urine sample collection and a pregnancy test for women of reproductive potential are also performed at entry Patients also receive immunizations At Weeks 12 and 16 a lyme vaccine polyvalent is administered At Week 36 lyme vaccine polyvalent pneumococcal vaccine polyvalent and haemophilus b conjugate HIB vaccine are administered AS PER AMENDMENT 051402 Lyme disease vaccine has been removed from the study due to unavailability At Week 48 skin tests are performed Week 52 is the final clinic visit at which blood is drawn and a urine sample is taken
Patients who participate in substudy A5140s undergo 2 lymph node aspirates at entry and at Week 48 Patients participating in substudy A5155s have blood drawn at screening and Week 48
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 |
|---|---|---|---|
| 10680 | REGISTRY | None | None |
| ACTG A5136 | None | None | None |
| AACTG A5136 | None | None | None |
| ACTG A5140s- Substudy | None | None | None |
| AACTG A5140s | None | None | None |
| ACTG A5155s- Substudy | None | None | None |
| AACTG A5155s | Registry Identifier | DAIDS ES | None |