HIV-1 infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: VS411
Product Code: VS411
Pharmaceutical Form: Capsule, hard
Current Sponsor code: VS411 (didanosina più idrossiurea)
Concentration unit: mg milligram(s)
Concentration type: equal
Produ
Sponsors
VIROSTATICS, SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provide written informed consent; Chronically HIV-1 infected patients; At least 18 years of age; Males or non-pregnant, non-lactating females; HIV-1 antiretroviral treatment naive; Plasma HIV-1 RNA levels > 5000 copies/mL; CD4+ T-cell count > 250 cells/mm3; CDC AIDS Surveillance Case Definition classification Stage A or B; Use of adequate and reliable forms of contraception during the study (males and females of childbearing potential) and starting at least one month prior to study drug administration for females and continuing for 30 days after discontinuation of study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - HIV-2 co-infection; - Primary (acute) HIV-1 infection; - 2 times the ULN), elevated liver transaminases (> 2 times the ULN), elevated bilirubin (> 2 times the ULN), elevated amylase (> 2 times the ULN), elevated lipase (> 2 times the ULN), decreased estimated creatinine clearance (< 60 mL/min) using the Cockcroft-Gault formula; - Use of co-medication with a known clinically significant pharmacological interaction with one or more of the study drugs (use of proton pump inhibitors are not allowed); - Active alcohol or drug abuse (methadone use is allowed); - Anticipated non-compliance with the protocol; - Anticipated need to start HAART within the study period; Presence of a newly (within 30 days) diagnosed HIV-related opportunistic infection or condition requiring acute therapy at the time of enrolment; Patients who have taken any investigational drug 30 days prior to the start of the study; Chronic active viral hepatitis; Pregnancy; Current or former pancreatitis; History of, or currently receiving, interferon therapy; Presence of didanosine-associated resistance mutations; Current or recent (within the prior three months) use of immunomodulatory agents (including vaccines); Current or recent (within the prior three months) use of ribavarin; Known allergy to the active or inactive components of VS411.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Main Objective: To characterize different dose combinations of hydroxyurea plus didanosine in the form of VS411 for further evaluation in phase IIb studies with respect to: - HIV-1 antiviral activity; - Pharmacokinetics; - Pharmacokinetic and pharmacodynamic relationships; - Quantification of intracellular ddATP/ dATP; - Immunological parameters; - Safety / tolerability; Evaluation of genotypic resistance to nucleoside/ nucleotide analogues at baseline and after four weeks of treatment.;Primary end point(s): - Changes from baseline in the log-transformed plasma HIV-1 RNA concentrations; - Plasma PK/PD of didanosine and hydroxyurea (didanosine also intracellularly); - Quantification of intracellular ddATP/ dATP - Changes in CD4+ T-cell counts; - Incidence and severity of adverse events; - Evaluation of genotypic resistance to nucleoside/ nucleotide analogues at baseline and after 28 days treatment | — |
Countries
Italy
Outcome results
None listed