HIV
Conditions
Interventions
Trade Name: Invirase
Product Name: Saquinavir mesylate
Product Code: n/a
Pharmaceutical Form: Coated tablet
Trade Name: Norvir
Sponsors
St Stephen's AIDS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements. 2. Male or non-pregnant, non-lactating females. 3. Between 18 to 65 years, inclusive. 4. Documented HIV-1 infection and plasma HIV RNA at screening visit below 50 copies/mL. (Note retesting of screening viral load is allowed). 5. Receiving a stable ARV regimen that includes saquinavir/ritonavir and 2 or more NRTIs for at least two weeks before the screening. 6. Agrees not to change saquinavir/ritonavir regimen from screening until end of the treatment period (except for the dose change in saquinavir/ritonavir as described in the Protocol), unless this is medically indicated as decided by the treating physician 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. Have a body mass index (BMI) >30 3. 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 4. Clinically relevant alcohol or drug use (positive urine drug screen) 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. Smoking is permitted, but tobacco intake should remain consistent throughout the study. 5. Concurrent non-nucleoside reverse transcriptase inhibitor (NNRTI) use 6. Concurrent protease inhibitors apart from the use of ritonavir at doses less than or equal to 100 mg twice daily. 7. The use of disallowed concomitant therapy (See Concomitant Medication and treatment, section 4.4). 8. Females of childbearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period. 9. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial. 10. Subjects with clinical or laboratory evidence of significantly decreased hepatic function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Blood levels of saquinavir ;Main Objective: • To compare the pharmacokinetic profile of saquinavir at steady state in HIV-infected patients following three consecutive administrations of saquinavir/ritonavir 1000/100 mg under fasting and fed conditions;Secondary Objective: • To assess the safety and tolerability of saquinavir/ritonavir 1000/100 mg b.i.d. in HIV-infected patients. | — |
Countries
United Kingdom
Outcome results
None listed