Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038272
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-05-29
Brief Title:
A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Pilot Study of Beta-D-26-diaminopurine Dioxolane DAPD Versus DAPD Plus Mycophenolate Mofetil MMF in Treatment-Experienced Subjects
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:
The purpose of this study is to evaluate the safety efficacy and side effects of beta-D-26-diaminopurine dioxolane DAPD compared to DAPD plus mycophenolate mofetil MMF when these drugs are added to the anti-HIV treatment regimens of people infected with HIV
Some studies have shown that DAPD and MMF can help fight HIV However neither DAPD nor MMF has been approved by the Food and Drug Administration for treating HIV infection This study will help doctors decide if DAPD and MMF are good drugs for treating HIV
Some studies have shown that DAPD and MMF can help fight HIV However neither DAPD nor MMF has been approved by the Food and Drug Administration for treating HIV infection This study will help doctors decide if DAPD and MMF are good drugs for treating HIV
Detailed Description:
The antiretroviral potency of DAPD varies among antiretroviral-experienced patients In vitro studies indicate that the potency of DAPD can be markedly increased by the addition of MMF Preliminary data indicate that MMF is well tolerated in patients with advanced HIV-1 disease However there is currently no clinical data on the activity of DAPD combined with MMF This study will be the first to evaluate the addition of DAPD and MMF to a patients current antiretroviral therapy
At study entry patients will be randomly assigned to one of two blinded treatment arms Arm A receives DAPD plus MMF placebo in addition to their current regimen while Arm B receives DAPD plus MMF in addition to their current regimen All patients remain on their current antiretroviral regimen through Week 2 After Week 2 patients who virologically respond are encouraged to remain on blinded study treatment through Week 24 Patients who do not virologically respond are unblinded
After unblinding patients who were not receiving MMF may add it to their antiretroviral regimen Response to the addition of open-label MMF is assessed after 2 weeks Resistance to antiretroviral agents including DAPD will be assessed following any virologic failure occurring after Week 2 All patients have the option of optimizing their background antiretroviral regimen at Week 2 based on the results of a pre-entry resistance assay enfuvirtide will be made available for background therapy optimization through Week 48
Patients who are still receiving DAPD alone or DAPD plus MMF at Week 48 and who are still responding virologically may choose to continue the study drugs and be followed for up to an additional 48 weeks Throughout the study HIV-1 RNA levels CD4 cell counts and study drug levels will be monitored regularly Eye exams will be done at several study visits Only DAPD MMF and MMF placebo will be supplied by this study patients must obtain the rest of their treatment regimen through their doctor Patients who discontinue treatment before the end of study will need to come in for a follow-up visit 4 weeks after discontinuation and may need to attend future follow-up visits at 8-week intervals as determined by the investigator
At study entry patients will be randomly assigned to one of two blinded treatment arms Arm A receives DAPD plus MMF placebo in addition to their current regimen while Arm B receives DAPD plus MMF in addition to their current regimen All patients remain on their current antiretroviral regimen through Week 2 After Week 2 patients who virologically respond are encouraged to remain on blinded study treatment through Week 24 Patients who do not virologically respond are unblinded
After unblinding patients who were not receiving MMF may add it to their antiretroviral regimen Response to the addition of open-label MMF is assessed after 2 weeks Resistance to antiretroviral agents including DAPD will be assessed following any virologic failure occurring after Week 2 All patients have the option of optimizing their background antiretroviral regimen at Week 2 based on the results of a pre-entry resistance assay enfuvirtide will be made available for background therapy optimization through Week 48
Patients who are still receiving DAPD alone or DAPD plus MMF at Week 48 and who are still responding virologically may choose to continue the study drugs and be followed for up to an additional 48 weeks Throughout the study HIV-1 RNA levels CD4 cell counts and study drug levels will be monitored regularly Eye exams will be done at several study visits Only DAPD MMF and MMF placebo will be supplied by this study patients must obtain the rest of their treatment regimen through their doctor Patients who discontinue treatment before the end of study will need to come in for a follow-up visit 4 weeks after discontinuation and may need to attend future follow-up visits at 8-week intervals as determined by the investigator
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 |
|---|---|---|---|
| AACTG A5165 | Registry Identifier | DAIDS ES | None |
| 10090 | REGISTRY | None | None |
| ACTG A5165 | None | None | None |