A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of virological failure in HIV-1 infected patients.

The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients

NCT02473328

HIV-1 Infection

COMPLETED PHASE2

Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

NCT02951052

Infection, Human Immunodeficiency Virus HIV Infections

ACTIVE_NOT_RECRUITING PHASE3

A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

NCT03198884

HIV-1-infection

COMPLETED

Pilot Study of a Raltegravir Based NRTI Sparing Regimen

NCT00814879

Acquired Immune Deficiency Syndrome AIDS Human Immunodeficiency Virus +1 more

COMPLETED NA

A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

NCT00135343

HIV Infections

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study design;

• 24-week prospective, single-arm, monocentric, open label, pilot study Participants will be seen at screening, baseline, day 8 and at week 4, 8, 12, 16, 24.

At each visit the following evaluations will be performed:

* clinical assessment.
* routine laboratory tests (hematological tests and clinical chemistry) including hemochromocytometric examination with leukocytic formula, creatinine, creatine kinase, transaminases, phosphorus, calcium, alkaline phosphatase, total and direct bilirubin, gammaGT, uric acid, lactate dehydrogenase, urine analysis, glucose, lipid profile, HIV-RNA and CD4 cell counts.

Additional blood samples will be collected at each visit for storage and further determinations.

During follow-up, at different timepoints, patients will additionally undergo:

* HbA1c and fasting insulin levels and HOMA-IR determination (baseline, week 12, week 24)
* Adherence assessment (questionnaire and/or pills counts) at week 4, 12 and 24.
* ECG (baseline and week 24)

Protocol virologic failure is defined as

* \< 1 log10 decrease in plasma HIV-1 RNA by week 12, with subsequent confirmation, unless plasma HIV-RNA \< 200 copies/ml OR
* a confirmed rebound in plasma HIV-RNA levels ≥ 50 copies/ml after prior confirmed suppression to \< 50 copies/ml OR a confirmed plasma increase in HIV-1 RNA levels \> 1log10 copies/ml above the nadir value where nadir is ≥ 50 copies/ml OR
* a plasma HIV-1 RNA level ≥ 50 copies/ml at week 24

Subjects who meet a protocol-defined virologic failure during follow-up will be discontinued from the study.

Patients who suppress HIV-1 RNA \< 50 cp/ml before week 24 and have a viral blip ≥ 50 copies/ml at week 24 will undergo a plasma HIV-1 RNA re-test to confirm the virologic failure. At virologic failure subjects will perform genotypic and phenotypic tests and a plasma determination of ATV and DTG Cthrough.

No changes in study treatment are allowed with the exception of ritonavir (RTV) discontinuation in patients with hyperbilirubinemia and/or gastrointestinal adverse events judged as RTV-related by the Investigator. In this case, subjects will remain on study using the regimen ATV 400mg QD + DTG 50mg QD. The discontinuation of RTV will not be considered as treatment failure.

In subjects with plasma HIV-RNA \< 50 copies/ml at week 24, the study treatment will be successively provided by Italian National Health system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open label single arm

Introduction of treatment regimen with atazanavir 300mg qd + ritonavir 100mg qd + dolutegravir 50mg qd

Group Type EXPERIMENTAL

atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg

Intervention Type DRUG

Switch to single arm treatment atazanavir-ritonavir 300-100 mg + dolutegravir 50 mg therapy for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg

Switch to single arm treatment atazanavir-ritonavir 300-100 mg + dolutegravir 50 mg therapy for 24 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Reyataz 300 mg + norvir 100 mg + tivicay 50 mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with age more than 18 years
* Willing and able to provide informed consent
* Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA more than 200 copies/ml)
* Any CD4 cell count
* Virus susceptible to atazanavir, defined as a genotypic mutation score inferior to 15 according to the HIV drug resistance database (Stanford University)
* No previous documented virologic failure during an atazanavir-containing regimen
* No previous exposure to integrase inhibitors
* Absolute neutrophil count (ANC) more than 500/mm3
* Haemoglobin more than 8.0 g/dL
* Platelet count more than 60,000/mm3
* e-GFR\> 60 ml/min using CKD-EPI equation

Exclusion Criteria

* Active AIDS-defining condition at Screening
* Serious illness requiring systemic treatment and/or hospitalization
* Current use of immunomodulant or immunosuppressive drugs
* Requirement for any concomitant medications that are prohibited with any study drugs (protocol section 3.6)
* History or presence of hypersensitivity to any of the active substances or to the excipients
* Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN), OR ALT more than 3xULN and bilirubin more than 1.5xULN (with more than 35 percent direct bilirubin)
* Subjects positive for Hepatitis B at screening (HBsAg positive)
* Subjects with anticipated need for Hepatitis C virus (HCV) therapy during the study
* Presence of moderate or severe hepatic impairment (defined as a Class B or C at Child Pugh Classification) or presence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Pregnancy or pregnancy wish; breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No