Status:
COMPLETED
Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects
Lead Sponsor:
ApoPharma
Conditions:
HIV Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02191657
Start Date
November 1 2006
End Date
April 1 2010
Last Update
July 16 2014
Active Locations (1)
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1
PAREXEL International
Bloemfontein, South Africa, 9324