Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867083
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-04-20
Brief Title:
Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Randomized Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 77 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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 trial is an open-label multicenter prospective randomized trial in 2 parallel groups evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 77 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy
Detailed Description:
Open-label multicenter prospective randomized trial in 2 parallel groups evaluating at W48 the non-inferiority of antiretroviral dual therapy taken 4 consecutive days a week versus dual therapy taken 7 days a week in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral dual therapy since 4 months The non-inferiority margin delta is 5 The randomization will be stratified according to the family of the dual therapy at the moment of the inclusion and according to the participation of the substudy or not
The sample size calculation assumes that the true difference in efficacy between the two arms is zero and that the overall response rate is 97 at week 48 A total of 440 patients 220 per arm is required to provide 80 power to demonstrate non-inferior efficacy for the 47 strategy compared to the daily dual therapy 77 with a two-sided significance level of 5 and a non-inferiority margin delta of -5
The sample size calculation assumes that the true difference in efficacy between the two arms is zero and that the overall response rate is 97 at week 48 A total of 440 patients 220 per arm is required to provide 80 power to demonstrate non-inferior efficacy for the 47 strategy compared to the daily dual therapy 77 with a two-sided significance level of 5 and a non-inferiority margin delta of -5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2020-003951-13 | EUDRACT_NUMBER | None | None |