A pilot evaluation of the pharmacokinetic and safety characteristics of TMC114/ritonavir and TMC125 co-administered to HIV-1-infected subjects with limited treatment options - Pilot PK study of TMC114/Ritonavir and TMC125

Phase 1

• Conditions: HIV

• Registration Number: EUCTR2005-003841-14-GB
• Lead Sponsor: St Stephens AIDS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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 female, between 18 to 65 years, inclusive.
3. Documented HIV-1 infection and detectable plasma viral load at the screening visit.
4. Receiving a stable antiretroviral regimen (including three or more drugs) for at least 12 weeks before screening.
5. Subject with documented failure to at least three classes of available antiretroviral agents.
6. Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 30 days following last dose of study drug:
-barrier contraceptives (condom, diaphragm with spermicide)
-oral, implant or injectable hormonal contraceptive PLUS a barrier contraceptive
IUD PLUS a barrier contraceptive (or a partner who has been vasectomized for at least six months).
7. Female subjects of childbearing potential must have a negative serum pregnancy test.
8. Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 30 days following last dose of study drug.

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 (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, malignancy, and any currently active AIDS defining illness (according to the CDC Classification System for HIV infection 1993).
2. 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.
3. Any medication taken listed in Section 6.2 (Prior and Concomitant Therapy) including over-the-counter medications and herbal products within 14 days of commencing study drug dosing. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
4. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial.
5. Positive drug screening at two consecutive drug screening (a positive drug screening will be repeated between screening and day 1). The drug screening involves analysis for amphetamine, barbiturates, benzodiazepines, cocaine, and opioids (patients with a positive drug screening for cannabinoids will be allowed in the study).
6. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels.
Note: subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable, and are not expected to require treatment during the study period and have transaminase levels = 3 x ULN. Subjects diagnosed with aute hepatitis A at screening will not be allowed in the trial.
7. ALT and/or AST > 5 x ULN.
8. Subjects with laboratories abnormalities of grade 3 or 4 as defined by the DAIDS grading scheme (Appendix 5), with the exception of:
-subjects with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4
-subjects with asymptomatic triglyceride or cholesterol elevations grade 4

Study & Design

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