Effect of food on the pharmacokinetic profile of saquinavir at steady state in HIV-infected patients treated with saquinavir/ritonavir 1000/100 mg b.i.d. - Saquinavir food pharmacokinetic study

Phase 1

• Conditions: HIV

• Registration Number: EUCTR2005-004430-41-GB
• Lead Sponsor: St Stephen's AIDS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified