Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects

ApoPharma

Status and phase: Completed; Phase 1

Conditions: HIV Infection

Treatments: Drug: Deferiprone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02191657

LA26-106

Details and patient eligibility

About

The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of different dosages of deferiprone in subjects with or without HIV infection.

Full description

Three cohorts were enrolled: two of individuals who were asymptomatically infected with HIV and one of healthy volunteers. Dosages were as follows:

• Cohort 1 (asymptomatic HIV infected subjects): 33 mg/kg deferiprone three times daily for a total of 99 mg/kg/day
• Cohort 2 (healthy volunteers): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day
• Cohort 3 (asymptomatic HIV infected subjects): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day

Enrollment: 26 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged ≥18 years and ≤ 60 years.
• Absolute neutrophil count (ANC) of >1000/mm3 for African black population and ≥ 1600/mm3 for all other races.
• For Cohort 2: HIV-negative
• For Cohorts 1 and 3: HIV-1 positive; CD4 count of at least 300/mm3; HIV-1 RNA copies (viral load) >10 000 copies/mL serum; and current physical health stable and not requiring antiretroviral treatment
• For Cohorts 1 and 3: Chest x-ray showing absence of active infectious diseases (such as tuberculosis, viral or atypical bacteria or parasitic infection).

Exclusion criteria

• Presence of any severe concomitant disease.
• History of or current, recurrent or recent (4 weeks) febrile disease.
• History of opportunistic infections, neoplasm or AIDS-defining conditions.
• Inability to discontinue any medication from screening onwards, or for at least 2 weeks before the first admission; in particular any antiviral or therapy with immunosuppressive activity.
• Significant liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 2.5 times the upper normal limit.
• Significant kidney impairment: serum creatinine ≥ two times the upper normal limit.
• Any concomitant disorder or resultant therapy likely to have interfered with subject compliance or with study procedures.
• Known hypersensitivity to any of the test materials or related compounds.
• Positive test for Hepatitis B and/or C antibodies.
• A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.
• History of seizures or epilepsy.

Trial design

26 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Subjects in this arm were asymptomatic HIV-infected individuals who received a dose of 33 mg/kg deferiprone three times a day for a total daily dosage of 99 mg/kg

Treatment:

Drug: Deferiprone

Cohort 2

Experimental group

Description:

Subjects in this arm were healthy volunteers who received a dose of 50 mg/kg deferiprone three times a day for a total daily dosage of 150 mg/kg

Treatment:

Drug: Deferiprone

Cohort 3

Experimental group

Description:

Subjects in this arm were asymptomatic HIV-infected individuals who received a dose of 50 mg/kg deferiprone three times a day for a total daily dosage of 150 mg/kg.

Treatment:

Drug: Deferiprone