Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

Withdrawn before enrolling · Phase 3

Conditions studied: HIV

In brief

The purpose of this study is to determine the proportion of subjects with HIV-1 RNA \< 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor

Key facts

Study ID: NCT01605084
Run by: Bristol-Myers Squibb
People needed: 0
Starts: 2012-06-30
Expected to finish: 2014-08-31
Last updated by the study team: 2023-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed informed consent.
HIV-1 infected patients with viremia (VL ≥ 500/mL) on or after their first NNRTI or INI-based cART regimen and meeting one of the two criteria below:.
i) On 1st line Non-nucleoside reverse transcriptase inhibitor (NNRTI) or Integrase inhibitor (INI)-based Combination antiretroviral therapy (cART) with HIV-1 RNA ≥ 500 c/ML after being on the same therapy for at least 12 weeks.
ii) Off 1st line NNRTI or INI-based Combination antiretroviral therapy (cART) for at least 2 weeks after having been on antiviral therapy for at least 4 weeks and who are non-compliant and off first line cART without a history of virologic failure with resistance, with a : HIV-1 RNA ≥ 500 c/ML.
Fully sensitive genotype and phenotype report for Atazanavir/Ritonavir (clinical cut-off of 5.2) and Darunavir/Ritonavir (clinical cut-off ranging from 10 to 90).
At least one NRTI other than Lamivudine (3TC) or emtricitabine (FTC) with full sensitivity (one "active" NRTI) by genotype and phenotype, ie, PhenoSense Genotype (GT), report must provide a "sensitive" net assessment of susceptibility. An NRTI or PI (reported with or without ritonavir) with a "partially sensitive" net assessment will not be considered "fully sensitive".
Mentally able to participate in the study.
Men and women ≥ 18 years old.
Women of child bearing potential who engage in vaginal intercourse and who are not clinically sterilized must use highly effective methods of birth control during the study.

You may not qualify if…

Screening HIV genotype showing presence at baseline of any of the following Protease inhibitor (PI) Mutation Patterns associated with genotypic resistance to Atazanavir sulfate/ Ritonavir or Darunavir/Ritonavir will lead to exclusion:.
i) Subjects with any darunavir associated mutations* at baseline (*V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V).
ii) Subjects with a major mutation to Atazanavir sulfate consisting of N88S.
iii) Subjects with more than 3 of any of the following Atazanavir sulfate related mutations:D30N, M36I/V, M46I/L/T, I54V/L/T/M/A, A71V/T/I/G, G73S/A/C/T, V77I, V82A/F/T/S/I, I84V/A, N88D or L90M.
Subjects with < 1 fully active NRTI on PhenoSense report, other than lamivudine and emtricitabine.
Diagnosed with active tuberculosis.
Chronic hepatitis B infection.
Hepatitis C-positive patients who are not clinically stable or need treatment during the study period.
Acute hepatitis in the 30 days prior to study entry.
Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug.
Intractable diarrhea within 30 days prior to study entry.
Presence of a newly diagnosed Human immunodeficiency virus (HIV)-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
Subject's with Cushing's syndrome.
Untreated hypothyroidism or hyperthyroidism.
Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
Subject's with obstructive liver disease.
Active alcohol or illegal substance use.
Inability to swallow capsules.
Active peripheral neuropathy.
Presence of cardiomypathy or any significant cardiovascular disease.
Known, clinically significant cardiac conduction system disease.
Physical and Laboratory Test Findings:.
i) Moderate to severe hepatic insufficiency.
ii) Screening laboratory values as follows:.
A. T4 < 4mcg/dL or >11mcg/dL and/or Thyroid-stimulating hormone (TSH) <0.5mU/L or >5.0mU/L.

Where it is running

Southwest Center For Hiv/Aids — Phoenix, Arizona, United States
Southwest Center For Hiv/Aids — Phoenix, Arizona, United States
Health For Life Clinic Pllc — Little Rock, Arkansas, United States
Anthony M. Mills Md Inc — Los Angeles, California, United States
Uc Davis Medical Center — Sacramento, California, United States
Metropolis Medical Pc — San Francisco, California, United States
Indiana University Hospital — Indianapolis, Indiana, United States
Be Well Medical Center — Berkley, Michigan, United States
Southampton Health Center — St Louis, Missouri, United States
Southampton Health Center — St Louis, Missouri, United States
I.D. Care Associates — Hillsborough, New Jersey, United States
Saint Michael'S Medical Center — Newark, New Jersey, United States
James J Peters VAMC — The Bronx, New York, United States
Infectious Disease Clinic & AI — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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