EUCTR2018-000497-30-ES
Active, not recruiting
Phase 1
Phase II clinical trial to evaluate the safety and efficacy of Vedolizumab combined with antiretroviral treatment to achieve functional healing in people infected with HIV-1 without previous antiretroviral treatment.
Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)0 sites12 target enrollmentMarch 14, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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