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Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

An Open-Label Phase 3B Study in HIV-Infected Individuals With Viremia on or After Their First-Line Non-Nucleoside Reverse Transcriptase Inhibitor or Integrase Inhibitor-Based Regimen and Starting a Second-Line Regimen Consisting of ATV/RTV or DRV/RTV With an Optimized NRTI Backbone

NCT01605084•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Detailed Description

Allocation: Randomization will be stratified * ATV = Atazanavir * DRV = Darunavir * RTV = Ritonavir

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•\- 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.
+36 more criteria

Locations (14)

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

Key Dates

Start Date

June 30, 2012

Primary Completion Date

August 31, 2014

Completion Date

August 31, 2014

Last Updated

December 19, 2023

Conditions

HIV

Interventions

Atazanavir

DRUG

Darunavir

DRUG

Ritonavir

DRUG

Optimized NRTI backbone

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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