Trial | NCT02191657  Report issue

Title

Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects
A Double Blind, Placebo-controlled, Dose-escalating, Multiple Dose Study, Investigating the Safety, Antiretroviral Activity, Tolerability and Pharmacokinetic Profile of Deferiprone When Administered in Healthy Volunteers and Asymptomatic HIV Infected Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    26
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.
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
Study Started
Nov 30
2006
Primary Completion
May 31
2008
Study Completion
Apr 30
2010
Last Update
Jul 16
2014
Estimate

Drug Deferiprone

Oral iron chelator

  • Other names: Ferriprox, L1

Cohort 1 Experimental

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

Cohort 2 Experimental

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

Cohort 3 Experimental

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.

Criteria 

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.
No Results Posted