Rapid ART Initiation with B/F/TAF in HIV people presenting with advanced HIV disease

Phase 1

• Conditions: HIV infection; MedDRA version: 20.0Level: LLTClassification code 10020441Term: Human immunodeficiency virus infection, unspecifiedSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-003614-14-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: 2020-10-07
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.Age > 18 years;
2.Newly diagnosed with HIV-1 infection within 7 days before the enrolment with either:
a)Confirmed or suspected AIDS defining event at screening (see appendix xx for AIDS defining conditions) or;
b)Patients with CD4 cell count < 200 µl at the determination closest to the study entry.
3.Naïve to antiretroviral therapy
4.Women of childbearing age must accept the use of one of the following contraceptive methods, starting from screening to the end of the study:
- Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal);
- Progestin hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable);
- Intrauterine devices;
- Intrauterine devices with hormonal release system;
- Bilateral tubal ligation;
- Vasectomy of the partner;
- Sexual abstinence (for heterosexual intercourse);
• Men must accept a highly effective contraceptive method specified during heterosexual intercourse or practice sexual abstinence from the first dose throughout the study period.
5.Be able to understand and sign a 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

•Pregnant/breastfeeding women, or women who are willing to become pregnant or to breastfeed during study;
•Impaired renal function defined as CrCl below 30 mL/min according to the CKD-EPI formula;
•Severe hepatic impairment defined as Child-Pugh Class C;
•Pulmonary or extrapulmonary active tuberculosis or expected treatment requiring Rifampicin or Rifabutin
•Meningeal or disseminated cryptococcosis;
•Known hypersensitivity to the study drug, the metabolites or formulation excipients;
•Patients not able to subscribe informed consent;
•Using any concomitant therapy disallowed as per product labelling for the study drugs.
•Systemic cancer chemotherapy within 30 days prior to the study entry with the exclusion of Kaposi’s sarcoma and lymphomas

Study & Design

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