HIV-1 Infection Clinical Trial
Official title:
Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent Maintenance Therapy After a Successful Continuous Induction Therapy.
Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads > 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).
Methods:
Open-label, multicentric, prospective, non-randomized, non-controlled trial to evaluate at
48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3
days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12
months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a
therapeutic success defined by the absence of virological failure (2 consecutive viral loads
> 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change
of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).
Allocation: Non-randomized Endpoint Classification: Safety/Efficacy Study Primary Purpose:
Treatment
Enrollment: 100 patients
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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