Trial to evaluate the safety and efficacy of a research drug in combination with antiretroviral treatment to cure people infected with HIV-1 without antiretroviral treatment.

Phase 1

• Conditions: Adult patients infected with HIV and without previous antiretroviral treatment.; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2018-000497-30-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-14
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

- Patients with HIV infection and age = 18 years and <65 years.
- Detectable viremia (>1x104 copies RNA/ ml )
- Levels of CD4 + > 350 cells / µL.
- Accept analytical interruption of the treatment.
- 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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presence of major resistance mutations to any of the study drugs.
- Active opportunistic infections.
- Pregnancy.
- Active co-infection with hepatitis B or C virus or latent infection with untreated TB.
- Cirrhosis, portal hypertension and / or hypersplenism of any etiology.
- Past or current neoplasms subsidiary to treatment with steroids, immunomodulators or chemotherapy
- Laboratory abnormalities grade 3 or 4.
- Concomitant use of drugs with greater pharmacological interactions with the study drugs, according to the respective technical specifications of the products.
- Estimated creatinine clearance < 50ml / min.
- Have received any type of vaccination (eg, hepatitis B virus, influenza ...) two weeks before the start of the study.
- Cardiovascular disease (eg, angina, heart failure, recent acute coronary syndrome)
- Neurological or neuropsychiatric disease whose symptoms may interfere with the assessment of safety and tolerability.
- Active abuse of alcohol and / or drugs or any pattern of behavior that, in the opinion of the researcher, could interfere with adherence to study drugs

Study & Design

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