Study on Efficacy and safety of switch ElvitegraviR/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in patients with a HIV infectio

Phase 1

• Conditions: Treatment of HIV infection; MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-002006-39-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Age>18 years
•Diagnosis of HIV-1 infection during PHI as determined by at least one of the following criteria: a) positive HIV viral load (2000 copies/mL) and negative HIV Ab/Ag Combo or Western Blot test, b) positive HIV Ab/Ag Combo test and negative or undetermined Western Blot test; c) positive HIV Ab/Ag Combo test and incomplete Western Blot test (no p31 protein reactivity); d) recent infection confirmed by a positive HIV-1 EIA or Western Blot test and a documented negative HIV-1 EIA within the previous 6 months
•Being on first-line treatment of primary HIV-1 infection with either DRV/RTV or DRV/C +TDF/FTC + RAL treatment; minimum time on treatment is the time elapsed between start of ARV and first available HIV RNA <40 copies/ml
•Plasma HIV-1 RNA <40 copies/mL at least one HIV RNA test
•To have Genotyping Resistance Test before start of ARV without resistance mutations to any antiretroviral drug class
•A female subject is eligible to enter the study if it is confirmed that she is:
-Not pregnant confirmed by a negative serum pregnancy test
-Not breastfeeding
-Of non-childbearing potential (eg women who have had a hysterectomy or both ovaries removed or are postmenopausal women >54years of age with cessation for >12 months of previously occurring menses)
-Of childbearing potential (as defined in Appendix **) and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence (as defined in Appendix **) from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs.
-Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
•Written Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Exclusion criteria
•Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness
•Receipt of investigational research agents within 30 days prior to study entry
•Receipt of prior experimental HIV vaccines. Individuals who received a saline placebo in a prior HIV vaccine trial are not excluded, provided that they did not receive a sham vector or an adjuvant.
•Receipt of immunosuppressive medications or immune-modulators (e.g., cytokine therapy) within the past 6 months.
•Current anti-tuberculosis prophylaxis or therapy
•Serious illness other than acute HIV infection requiring systemic treatment or hospitalization until either therapy is completed or patient is clinically stable on therapy
•Hepatitis C (HCV Ab positive) or hepatitis B infection (Positive hepatitis B surface antigen, HBsAg)
•Women who are pregnant or breastfeeding
•Renal function with CrCl below 50 mL/min
•Severe hepatic impairment
•Known hypersensitivity to the study drug, the metabolites or formulation excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified