HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

Clinique du Quartier Latin

Status and phase: Unknown; Phase 4

Conditions: HIV Infections

Treatments: Drug: Doravirine

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04334551

Doravirine and HIV VT#59184

Details and patient eligibility

About

This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.

The study will be performed only on two sites

Full description

The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (18 Y.O. or more) women and men infected with HIV.

• Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
• Virologically controlled (HIV-1 RNA < 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
• Presence of at least one major NNRTI mutation.
• No limitation on the number of previous regimens.
• HCV and HBV-infected patients are allowed

Exclusion criteria

High level of resistance to doravirine according to historical resistance tests.

• Level of resistance to doravirine superior to that of etravirine
• Opportunistic or serious active infection or disease
• Active and untreated malignancy.
• Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
• Pregnancy.
• Active treatment for hepatitis C is forbidden at entry but will be allowed after 3

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

switch from etravirine to doravirine

Experimental group

Description:

switches to doravirine,

Treatment:

Drug: Doravirine