Asymptomatic HIV Infection
Conditions
Keywords
HIV infection, antiretroviral drugs, deferiprone, pharmacokinetics
Brief summary
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
Detailed description
This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.
Interventions
DRUGIntravenous deferiprone
In Cohort 1, the subjects who were randomized to get active product will receive deferiprone at a dose of 1.5 g per infusion, and if there are no significant safety concerns, the subjects in Cohort 2 who were randomized to get active product will receive it a a dose of 2 g per infusion.
DRUGPlacebo
In both cohorts, the subjects who were randomized to get placebo will receive an infusion of placebo solution that is equal in volume to that of the active product.
Sponsors
ApoPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 positive * HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen * HIV-1 RNA \> 10,000 copies/mL * ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range * Body mass index (BMI) of 18.5 to 30.0 kg/m\^2 * Absolute neutrophil count at baseline of ≥1.0 x 10\^9/L (black African population only) or ≥1.5 x 10\^9/L (all other races)
Exclusion criteria
* Evidence of AIDS-associated illness, excluding superficial candidiasis * CD4+ T-cell count of \< 350/mm\^3 * Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test * Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening * Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies * History or presence of malignancy * A serious, unstable chronic illness during the past 3 months before screening * A serious, unresolved acute illness at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HIV viral load | Day 1 to Day 56 |
| Change from baseline in CD4+ T-cell count | Day 1 to Day 56 |
| Change from baseline in level of HIV DNA in peripheral blood mononucleated cells | Day 1 to Day 56 |
| Proportion of subjects withdrawn due to the need for rescue medication | Day 1 to Day 56 |
| Number of subjects with adverse events | Day 1 to Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetics parameters of Cmax, Tmax, and AUC0-∞, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose | 10-hour interval |
Countries
South Africa
Outcome results
None listed