Finding studies
Finding studies
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Lead
International Antiviral Therapy Evaluation Center
With
This is a single centre, single arm study. Subjects will receive 5 consecutive daily doses of Suc-HSA at a dose of 10 mg/kg on days 0, 1, 2, 3 and 4 on the Special Investigation Unit (SIU), with a safety follow up on the SIU for 4 hours on day 1 and 2 hours on the next days. There will be follow-up visits on week 1, 2, 4 and 12. Standard safety parameters (physical examination, clinical symptoms, laboratory hematology and biochemistry) will be followed until week 12. Plasma HIV-1 RNA and CD4+/CD8+ cell counts will be assessed at every visit. Plasma drug levels (trough and peak) will be measured from baseline until week 2. 6 patients will be included in this study as described in this protocol amendment. Eligible subjects are chronic HIV-1 infected patients who have never been treated with antiretroviral treatment and for whom there is no need to start antiretroviral treatment. Test Product: Suc-HSA, a candidate HIV-1 fusion inhibitor. Duration of treatment: 5 days Criteria for evaluation: * Safety: symptoms, signs at physical examination, standard hematology and chemistry laboratory parameters- Efficacy: changes in plasma HIV-1 RNA and CD4+ T cell count * Pharmacokinetics: plasma levels of Suc-HSA: Cmin, Cmax and AUC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
