HIV
Conditions
Interventions
Trade Name: Reyataz
Product Name: Atazanavir
Pharmaceutical Form: Capsule, hard
Other descriptive name: atazanavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3
Sponsors
St Stephen's Aids Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements -Male or non-pregnant, non-lactating females. -Aged between 18 to 65 years, inclusive. -Documented HIV-1 infection -Plasma HIV RNA less than 40 copies/mL (note retesting of screening viral load is allowed). -CD4 count > 100 at screening (note retesting of screening CD4 count is allowed). -Receiving an antiretroviral regimen of Truvada and atazanavir/ritonavir for more than 3 months. -Serum total bilirubin concentration greater than 25 micromol/L -Agrees not to change regimen, outside the study recommendations, from baseline until end of the treatment period unless this is medically indicated as decided by their treating physician. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: -Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic disorders or malignancy. -Body mass index (BMI) >35 kg/m2 -Presence of any current active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: -Stable cutaneous Kaposi's Sarcoma -Clinically relevant alcohol or drug use (positive urine drug screen, with the exception of cannabinoids) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. -The use of disallowed concomitant therapy (See Concomitant Medication and treatment, section 5.2) or medication that may interfere with the study results (as determined by the principal investigator). -Females of childbearing potential who are not using effective non-hormonal birth control methods or not willing to continue using these birth control methods for at least 14 days after the end of the treatment period. -Previous allergy to any of the constituents of the zinc sulphate tablets administered in this trial. -Subjects with laboratory evidence of significantly decreased hepatic or renal function (as determined by the principal investigator). -Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in hyperbilirubinaemia (excess bilirubin in the blood) following intake of zinc sulphate along with regular therapy (atazanavir/ritonavir).;Secondary Objective: To assess the safety and tolerability of zinc sulphate supplement when given along with regular therapy (atazanavir/ritonavir). To investigate the link between genetic differences in DNA sequence in how genes react to drugs and drug exposure;Primary end point(s): Change in serum unconjugated bilirubin concentrations when atazanavir/ritonavir is added to zinc sulphate, adjusted for period effect. | — |
Countries
United Kingdom
Contacts
Public ContactDr Marta Boffito
St Stephen's Aids Trust
Outcome results
None listed