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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ApoPharma
• Treatments: Deferiprone

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.