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

NCT ID: NCT01638650

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

Intervention Type DRUG

in accordance with current clinical HIV treatment guidelines

ritonavir

Intervention Type DRUG

100 mg bid orally, Days 1-14

saquinavir [Invirase]

Intervention Type DRUG

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

Interventions

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Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

in accordance with current clinical HIV treatment guidelines

Intervention Type DRUG

ritonavir

100 mg bid orally, Days 1-14

Intervention Type DRUG

saquinavir [Invirase]

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NP25607

Identifier Type: -

Identifier Source: org_study_id