Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036452
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-05-10
Brief Title:
A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day With or Without Direct Observation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation
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:
Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor Because anti-HIV therapy often involves multiple drugs some people have difficulty taking them all correctly The easier it is to take anti-HIV drugs the more likely people will take them as prescribed and get the best results This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker Viral load amount of HIV in the blood and drug side effects will be measured
Detailed Description:
While many factors contribute to the success or failure of antiretroviral therapy for HIV among the most important are factors that influence adherence to a treatment regimen such as duration of therapy dosing frequency pill burden side effects and patient behaviors Inconsistent adherence or nonadherence to antiretroviral therapy can result in suboptimal drug exposure Suboptimal drug exposure can in turn impact short- and long-term patient outcomes by increasing the likelihood of drug resistant HIV mutants and subsequent virologic and clinical failure It is therefore essential to design treatment regimens that promote long-term adherence to potent antiretroviral therapy This study will evaluate the relative contribution of reduced-frequency dosing and directly observed therapy on the magnitude and durability of virologic suppression in patients treated with potent antiretroviral therapy
Patients will be randomly assigned to one of three study arms Arms A B and C receive the same daily dosage of lopinavirritonavir LPVr emtricitabine FTC and stavudine extended release d4T XR or tenofovir DF TDF In Arm A drugs are self-administered for 48 weeks LPVr is taken twice daily and FTC and d4T XR or TDF once daily In Arm B all drugs are self-administered once daily for 48 weeks In Arm C drugs are taken once a day under directly observed therapy during Weeks 0-24 and then by self-administration during Weeks 25-48 Adherence to the regimen is measured using an electronic drug monitoring system Viral load CD4 and CD8 T cell responses population pharmacokinetics and quality of life indicators are measured throughout the study The tolerability and safety of the treatment regimens are also monitored
Patients will be randomly assigned to one of three study arms Arms A B and C receive the same daily dosage of lopinavirritonavir LPVr emtricitabine FTC and stavudine extended release d4T XR or tenofovir DF TDF In Arm A drugs are self-administered for 48 weeks LPVr is taken twice daily and FTC and d4T XR or TDF once daily In Arm B all drugs are self-administered once daily for 48 weeks In Arm C drugs are taken once a day under directly observed therapy during Weeks 0-24 and then by self-administration during Weeks 25-48 Adherence to the regimen is measured using an electronic drug monitoring system Viral load CD4 and CD8 T cell responses population pharmacokinetics and quality of life indicators are measured throughout the study The tolerability and safety of the treatment regimens are also monitored
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 A5073 | Registry Identifier | DAIDS ES | None |
| 10073 | REGISTRY | None | None |
| ACTG A5073 | None | None | None |