Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021489
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2001-07-18
Brief Title:
Mycophenolate Mofetil and Abacavir Treatment in HIV Patients With Failed Anti-HIV Treatment
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 Study of the Safety Tolerability and Antiretroviral Activity of Mycophenolate Mofetil As an Adjunct to Abacavir Therapy in HIV-Infected Subjects With Treatment Failure and Extensive Prior Antiretroviral Exposure
Status:
WITHDRAWN
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 learn how safe and well-tolerated mycophenolate mofetil MMF is when given with abacavir ABC Another purpose is to see if adding MMF to ABC decreases viral load amount of HIV in the blood more than ABC alone
Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced treatment failure need new treatment combinations One promising combination is ABC and MMF as part of a drug combination Laboratory studies show that MMF helps ABC destroy HIV in the cells and further clinical testing is needed MMF is not FDA-approved as a treatment for HIV infection but has been approved by FDA to prevent rejection of organ transplants Doses of MMF tested in this study will be lower than those used to treat people with organ transplants
Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced treatment failure need new treatment combinations One promising combination is ABC and MMF as part of a drug combination Laboratory studies show that MMF helps ABC destroy HIV in the cells and further clinical testing is needed MMF is not FDA-approved as a treatment for HIV infection but has been approved by FDA to prevent rejection of organ transplants Doses of MMF tested in this study will be lower than those used to treat people with organ transplants
Detailed Description:
A large group of heavily drug-exposed HIV-infected individuals with detectable HIV-1 RNA exists as a result of the sequential use and failure of existing antiretroviral agents from each of the 3 antiretroviral drug classes nucleoside reverse transcriptase inhibitors NRTIs protease inhibitors PIs and nonnucleoside reverse transcriptase inhibitors NNRTIs Systematic approaches are needed to define salvage therapy regimens for this patient group This trial uses a short-term study to determine the initial safety pharmacology and antiviral potency of MMF in augmenting the antiretroviral effect of ABC which then can be appraised for use as a salvage regimen After rapid oral absorption MMF is hydrolyzed to form MPA mycophenolic acid the active metabolite Recent in vitro studies show that MPA concentrations as low as 625 nM synergistically increase the antiviral effect of ABC or ddI or of ABC in combination with ddI against multinucleoside-resistant HIV strains These observations suggest that MMF in combination with ABC might play a role in antiretroviral therapy in patients with drug resistance and continued clinical evaluation of MMF is warranted
At study entry patients stop current NRTIs but continue taking PIs and NNRTIs with study treatment The first 50 patients are stratified by plasma HIV-1 RNA below 40000 copiesml or 40000 and higher copiesml and randomized to either Arm A or Arm B Arm A receives ABC with MMF placebo Arm B receives ABC and MMF Only ABC and MMF are provided by the study Treatment is received for 4 weeks and patients are evaluated for safety tolerability and virologic response At Week 4 entry genotype results are provided to patients and antiretroviral therapy may then be altered as indicated Patients are unblinded to study treatment as soon as possible after Week 4 but no later than Week 7 Future opening of Arm C to 125 additional patients is delayed until the first 50 patients have reached Week 4 and an interim review of safety and virologic response is completed Responders may continue study treatment through Week 24 At 10 clinic visits patients have blood drawn for HIV-1 RNA determinations CD4 and CD8 cell counts and genotyping Patients may participate in pharmacokinetic substudy A5121s
At study entry patients stop current NRTIs but continue taking PIs and NNRTIs with study treatment The first 50 patients are stratified by plasma HIV-1 RNA below 40000 copiesml or 40000 and higher copiesml and randomized to either Arm A or Arm B Arm A receives ABC with MMF placebo Arm B receives ABC and MMF Only ABC and MMF are provided by the study Treatment is received for 4 weeks and patients are evaluated for safety tolerability and virologic response At Week 4 entry genotype results are provided to patients and antiretroviral therapy may then be altered as indicated Patients are unblinded to study treatment as soon as possible after Week 4 but no later than Week 7 Future opening of Arm C to 125 additional patients is delayed until the first 50 patients have reached Week 4 and an interim review of safety and virologic response is completed Responders may continue study treatment through Week 24 At 10 clinic visits patients have blood drawn for HIV-1 RNA determinations CD4 and CD8 cell counts and genotyping Patients may participate in pharmacokinetic substudy A5121s
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Substudy AACTG A5121s | Registry Identifier | DAIDS ES | None |
| 10927 | REGISTRY | None | None |
| ACTG A5105 | None | None | None |
| AACTG A5105 | None | None | None |