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Nucleoside Reverse Transcriptase Inhibitor

Phase 1

HIV Infections | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

Nucleoside Reverse Transcriptase Inhibitor · 1 trial · 1 indication

Phase 1 1
NCT01638650A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected PatientsHIV Infections
COMPLETED23 Analytics
PHASE1COMPLETED
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
Nucleoside Reverse Transcriptase Inhibitor (NRTIs)DRUGin accordance with current clinical HIV treatment guidelines
ritonavirDRUG100 mg bid orally, Days 1-14
saquinavir [Invirase]DRUG500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 regime...

Countries:United Kingdom
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Frequently asked questions about Nucleoside Reverse Transcriptase Inhibitor

What is Nucleoside Reverse Transcriptase Inhibitor used for?

Nucleoside Reverse Transcriptase Inhibitor is an investigational small molecule being developed for the treatment of HIV Infections. It is currently in Phase 1 clinical development, meaning it has not yet been approved and is still being studied for safety and efficacy in patients.

Who makes Nucleoside Reverse Transcriptase Inhibitor?

Nucleoside Reverse Transcriptase Inhibitor is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for HIV Infections.

What phase is Nucleoside Reverse Transcriptase Inhibitor in?

Nucleoside Reverse Transcriptase Inhibitor is in Phase 1 clinical development. It is an investigational drug for HIV Infections and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 23 participants.

What clinical trials is Nucleoside Reverse Transcriptase Inhibitor in?

Nucleoside Reverse Transcriptase Inhibitor has one completed clinical trial, NCT01638650, titled 'A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients.' This Phase 1 study enrolled 23 participants in the United Kingdom and was not randomized or double-blind.

Is Nucleoside Reverse Transcriptase Inhibitor the same as saquinavir?

The clinical trial NCT01638650 for Nucleoside Reverse Transcriptase Inhibitor studied ritonavir-boosted Invirase (saquinavir) in treatment-naïve HIV-1 infected patients. However, the drug name provided is Nucleoside Reverse Transcriptase Inhibitor, and no alternative names have been specified for this investigational drug.