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This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous deferiprone, 1.5 g | Experimental | Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily |
|
| Intravenous deferiprone, 2 g | Experimental | Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily |
|
| Placebo | Placebo Comparator | Subjects in this arm will receive an infusion of placebo twice-daily for 10 days, at a volume equivalent to that of the active product in the respective cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous deferiprone | Drug | 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. |
| Measure | Description | 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| Proportion of subjects withdrawn due to the need for rescue medication | Day 1 to Day 56 | |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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Pharma | Port Elizabeth | Eastern Cape | 6001 | South Africa | ||
| VxPharma |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D007531 | Isoflurophate |
| D000077543 | Deferiprone |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D063066 | Organofluorophosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 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. |
|
|
| Pretoria |
| 0087 |
| South Africa |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004364 | Pharmaceutical Preparations |