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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

ritonavir

saquinavir [Invirase]

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics: Plasma concentrations

Pharmacodynamics: Change in HIV-RNA levels

Safety: Incidence of adverse events

Change in ECG parameters

Correlation between saquinavir plasma concentration and QTc interval changes

Full Information

NCT ID

NCT01638650

First Posted

June 6, 2012

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01638650

Brief Title

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

Official Title

To Determine the Effect of the Modified SQV/r (Saquinavir-boosted by Ritonavir) Regimen (500/100 mg for the 1st Week Followed by 1000/100 mg for the 2nd Week) on the QTc Interval, Pharmacokinetics, and Antiviral Activity in Treatment-naive HIV-1 Infected Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

Intervention Description

in accordance with current clinical HIV treatment guidelines

Intervention Type

Drug

Intervention Name(s)

ritonavir

Intervention Description

100 mg bid orally, Days 1-14

Intervention Type

Drug

Intervention Name(s)

saquinavir [Invirase]

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Pharmacokinetics: Plasma concentrations

Time Frame

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

Title

Pharmacodynamics: Change in HIV-RNA levels

Time Frame

from baseline to Day 14

Title

Safety: Incidence of adverse events

Time Frame

approximately 6 months

Title

Change in ECG parameters

Time Frame

from baseline to Day 14

Title

Correlation between saquinavir plasma concentration and QTc interval changes

Time Frame

approximately 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

London

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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