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

NCT01638650 | Completed Phase 1

• 1 other identifier: NP25607
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Maximal increase in QTc interval (continuous Holter 12-lead ECG monitoring time points Days 1, 3, 4, 7, 10 and 14)

  14 days

Secondary Outcomes (5)

• Pharmacokinetics: Plasma concentrations

  Pre-dose and 2, 4, 6, 8 and 12 hours post-dose, Days 3, 4, 7, 10 and 14

• Pharmacodynamics: Change in HIV-RNA levels

  from baseline to Day 14

• Safety: Incidence of adverse events

  approximately 6 months

• Change in ECG parameters

  from baseline to Day 14

• Correlation between saquinavir plasma concentration and QTc interval changes

  approximately 6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs); Drug: ritonavir; Drug: saquinavir [Invirase]

Interventions

Nucleoside Reverse Transcriptase Inhibitor (NRTIs) DRUG

in accordance with current clinical HIV treatment guidelines

Single Arm

ritonavir DRUG

100 mg bid orally, Days 1-14

Single Arm

saquinavir [Invirase] DRUG

500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir; Saquinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: July 12, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)