Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084019
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-06-04
Brief Title:
AtazanavirRitonavir Maintenance Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Open-Label Pilot Trial of Regimen Simplification to AtazanavirRitonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression
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:
Long-term side effects the expense of medications and the difficulty of taking medications continuously for long periods of time are all problems with complicated anti-HIV drug regimens The purpose of this study is to determine whether two drugs atazanavir ATV and ritonavir RTV will control HIV infection when taken together without any other anti-HIV drugs after 48 weeks of viral suppression
Hypothesis Simplified maintenance therapy with ATV and RTV alone after virologic suppression does not markedly increase the risk of virologic failure
Hypothesis Simplified maintenance therapy with ATV and RTV alone after virologic suppression does not markedly increase the risk of virologic failure
Detailed Description:
The expense difficulty and long-term adverse events associated with sustained adherence to combination antiretroviral therapy emphasize the need for simpler alternative treatment strategies for HIV infection Studies have shown that single protease inhibitor PI maintenance therapy may provide sufficient virologic suppression while reducing the risk of nucleoside reverse transcriptase inhibitor NRTI-associated metabolic complications However it is not known whether ritonavir-boosted atazanavir ATVRTV maintenance therapy would be effective in controlling HIV replication in the genital compartments and whether viral load testing by blood collection would be effective in detecting elevated levels of HIV in the genital compartments This study will determine whether simplified maintenance therapy with ATVRTV after 48-week virologic suppression will increase the likelihood of virologic failure
This study will last 54 weeks Participants will undergo an electrocardiogram EKG at screening At study start participants will switch from their current PIs to ATVRTV and stay on their current NRTIs until Week 6 when they will discontinue their NRTIs and remain on a maintenance regimen of ATVRTV alone for the duration of the study Study visits will take place at Weeks 3 and 6 then every 4 weeks until Week 30 then every 8 weeks until the end of the study at Week 54 Medication assessment physical exam and blood work will occur at each study visit At Week 30 viral load will be measured in the genital secretions of both male and female study participants
This study will last 54 weeks Participants will undergo an electrocardiogram EKG at screening At study start participants will switch from their current PIs to ATVRTV and stay on their current NRTIs until Week 6 when they will discontinue their NRTIs and remain on a maintenance regimen of ATVRTV alone for the duration of the study Study visits will take place at Weeks 3 and 6 then every 4 weeks until Week 30 then every 8 weeks until the end of the study at Week 54 Medication assessment physical exam and blood work will occur at each study visit At Week 30 viral load will be measured in the genital secretions of both male and female study participants
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 A5201 | Registry Identifier | DAIDS ES | None |
| 10096 | REGISTRY | None | None |