A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients

Roche

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

Drug: ritonavir

Drug: saquinavir [Invirase]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01638650

NP25607

Details and patient eligibility

About

This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients. Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second week. The study treatment will be given in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines. Anticipated time on study treatment is 14 days.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/= 18 years of age
HIV-1 infection
Currently treatment-naïve and eligible to initiate a ritonavir-boosted Protease Inhibitor based regimen and willing and able to initiate saquinavir/ritonavir therapy for the first 14 days; the saquinavir/ritonavir regimen will be in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines
Body mass index 18-32 kg/m2, inclusive
Female patients of childbearing potential and male patients with female partners of childbearing potential must use 2 methods of contraception as defined by protocol during the study and for at least one month after the last dose of study drug
Non-smoker or patients who have stopped smoking more than three months prior to Day 1 of the study

Exclusion criteria

Coinfection with hepatitis B or C (acute or chronic)
Anticipated use or need for significant concomitant medical treatment during the study period, other than background antiretroviral therapy
Participation in a clinical study with an investigational drug or device within 3 months prior to Day 1 of the study
Pregnant or lactating women
Any clinically relevant history of substance abuse or addiction including alcohol and/or other drugs of abuse
Special dietary restrictions that would prohibit consumption of standardized meal (e.g. vegetarian, vegan, gluten-free, lactose-free, kosher)
Decompensated liver disease
Congenital or documented acquired QT prolongation
Electrolyte disturbances, particularly uncorrected hypokalaemia
Clinically relevant bradycardia
Clinically relevant heart failure with reduced left-ventricular ejection fraction
Previous history of symptomatic arrhythmias
History of clinically significant gastro-intestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, , hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis