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Nucleoside Reverse Transcriptase Inhibitor

Phase 1

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

Nucleoside Reverse Transcriptase Inhibitor target and mechanism

ModalitySmall molecule

Also known as Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Nucleoside Reverse Transcriptase Inhibitor clinical trials

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 being studied for the treatment of HIV Infections, an infectious disease indication. It is a small molecule therapeutic developed by Roche Holding AG. The compound is in Phase 1 clinical development, and the completed trial enrolled treatment-naive HIV-1 infected patients.

Who makes Nucleoside Reverse Transcriptase Inhibitor?

Nucleoside Reverse Transcriptase Inhibitor is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor behind the clinical program evaluating this small molecule in HIV Infections.

What phase is Nucleoside Reverse Transcriptase Inhibitor in?

Nucleoside Reverse Transcriptase Inhibitor is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is Nucleoside Reverse Transcriptase Inhibitor in?

Nucleoside Reverse Transcriptase Inhibitor has been evaluated in the Phase 1 trial NCT01638650, titled A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naive HIV-1 Infected Patients. That trial was completed, enrolled 23 participants, used a randomized design, and was conducted in the United Kingdom.

Is Nucleoside Reverse Transcriptase Inhibitor the same as NRTIs?

Yes. Nucleoside Reverse Transcriptase Inhibitor is also known as Nucleoside Reverse Transcriptase Inhibitor (NRTIs). The abbreviated form NRTIs refers to the same drug asset developed by Roche Holding AG for HIV Infections.

What is the enrollment and design of the Nucleoside Reverse Transcriptase Inhibitor trial?

The completed Phase 1 trial of Nucleoside Reverse Transcriptase Inhibitor, NCT01638650, enrolled 23 participants. It was a randomized study without a control group and was not double blinded. Participants were 18 years of age or older, of all sexes, and were not healthy volunteers.