Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028314
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2001-12-20
Brief Title:
Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Restrictively Randomized Open-Label Controlled Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting
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:
The goals of this study are to find out if fat wasting and weight loss in the arms and legs of HIV patients taking highly active antiretroviral therapy HAART are caused by nucleosidenucleotide reverse transcriptase inhibitors NRTIs and if wasting can be reversed if the NRTI is stopped and replaced with other anti-HIV drugs
Detailed Description:
Recent studies suggest body shape changes fat redistribution and fat lipoatrophy may be related to the NRTI component of patients HAART and not to the protease inhibitor PI component The hypothesis of this study is that thymidine analogues such as stavudine d4T and zidovudine ZDV cause lipoatrophy more so than non-thymidine analogues and that removal of thymidine analogues from HAART in patients with defined lipoatrophy will reverse this process
In Step 1 patients will undergo axial mid-thigh and abdomen computer tomography CT scans If the CT scans are readable patients are restrictively and randomly assigned to 1 of 2 treatment arms in Step 2 Patients in Arm A-1 will replace the thymidine analogue component stavudine d4T or zidovudine ZDV of their HAART with abacavir ABC Patients in Arm B-1 will discontinue their current HAART and will receive a PI and a nonnucleoside reverse transcriptase inhibitor NNRTI either lopinavirritonavir LPVr and nevirapine NVP or atazanavir ritonavir and NVP Patients currently on efavirenz EFV not provided by the study may choose to continue with EFV instead of switching to NVP Comparisons will be made to the baseline values of subcutaneous fat measured by mid-thigh and abdominal CT Patients in Arms A-1 and B-1 remain on study for a total of 48 weeks and do not advance to Step 3
Two additional groups Arms A-2 and B-2 made no changes to HAART for 28 weeks to evaluate the natural history of change in lipoatrophy over time accrual into these groups and into Step 3 has been discontinued At Week 28 patients in Arms A-2 and B-2 were registered to Step 3 and switched from HAART to a designated new treatment Arm A-2 patients will replace d4T or ZDV with ABC for 48 weeks Arm B-2 patients replace their HAART with LPVr plus NVP for 48 weeks If patients in Arms A-2 and B-2 have not completed the 28-week delay and have not switched regimens they will enter Step 4 and be reregistered into Arms A-1 and B-1 respectively remaining on their treatment assignment for 48 weeks If patients in Arms A-2 and B-2 have already switched regimens then they will continue on their new regimens until Week 76
In Step 1 patients will undergo axial mid-thigh and abdomen computer tomography CT scans If the CT scans are readable patients are restrictively and randomly assigned to 1 of 2 treatment arms in Step 2 Patients in Arm A-1 will replace the thymidine analogue component stavudine d4T or zidovudine ZDV of their HAART with abacavir ABC Patients in Arm B-1 will discontinue their current HAART and will receive a PI and a nonnucleoside reverse transcriptase inhibitor NNRTI either lopinavirritonavir LPVr and nevirapine NVP or atazanavir ritonavir and NVP Patients currently on efavirenz EFV not provided by the study may choose to continue with EFV instead of switching to NVP Comparisons will be made to the baseline values of subcutaneous fat measured by mid-thigh and abdominal CT Patients in Arms A-1 and B-1 remain on study for a total of 48 weeks and do not advance to Step 3
Two additional groups Arms A-2 and B-2 made no changes to HAART for 28 weeks to evaluate the natural history of change in lipoatrophy over time accrual into these groups and into Step 3 has been discontinued At Week 28 patients in Arms A-2 and B-2 were registered to Step 3 and switched from HAART to a designated new treatment Arm A-2 patients will replace d4T or ZDV with ABC for 48 weeks Arm B-2 patients replace their HAART with LPVr plus NVP for 48 weeks If patients in Arms A-2 and B-2 have not completed the 28-week delay and have not switched regimens they will enter Step 4 and be reregistered into Arms A-1 and B-1 respectively remaining on their treatment assignment for 48 weeks If patients in Arms A-2 and B-2 have already switched regimens then they will continue on their new regimens until Week 76
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 |
|---|---|---|---|
| ACTG A5110 | None | None | None |
| AACTG A5110 | None | None | None |