Last updated 23 days ago

Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

40 patients around the world

Available in Brazil

Federal University of São Paulo

40Patients around the world

This study is for people with

Hiv

Requirements for the patient

To 50 Years

Male

Medical requirements

: Confirmed HIV infection.
Antiretroviral naive.
HIV Viral load > 1.000.
CD4+ T cell counts >350 cells/mm3.
Body weight > 50 Kg.
Signed informed consent form.

: BMI < 18.5 kg/m2 at screening.
Coinfection with HBV (HBsAg +) or HCV.
Any significant acute illness within one week before the first visit.
Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening.
Active malignancy or malignancy in follow-up.
Changes in safety tests: neutrophil count < 1,000 u/L; Hb < 9.0 gm/dl; platelet count < 75,000 u/L; creatinine > 1.5 mg/dl, direct bilirubin > 85 μmol/L, AST or ALT > 2.5 X UNL.
Potential allergy or hypersensitivity to the components of the Gammora® formulation.
Participation in another clinical trial within 12 months before screening.
Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.

SponsorFederal University of São Paulo

Study typeInterventional

Conditions

Hiv

Requirements

To 50 YearsMale

Unique study IDclinicaltrials.gov

NCT06799650