Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

April 4, 2017 updated by: Bristol-Myers Squibb

Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
710

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Local Institution
      • Buenos Aires, Argentina, 1155
        • Local Institution
      • Buenos Aires, Argentina, 1650
        • Local Institution
      • Buenos Aires, Argentina, 1202
        • Local Institution
      • Cordoba, Argentina, X5000BJH
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution
  • Brazil
      • Rio De Janeiro, Brazil, 21040000
        • Local Institution
      • Sao Paulo, Brazil, 01246
        • Local Institution
    • Parana
      • Curitiba, Parana, Brazil, 80060
        • Local Institution
      • Curitiba, Parana, Brazil, 80240
        • Local Institution
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52052
        • Local Institution
    • Rio De Janeiro
      • Rio De Janeiro - Rj, Rio De Janeiro, Brazil, 22271
        • Local Institution
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083
        • Local Institution
      • Sao Paulo - Sp, Sao Paulo, Brazil, 01246
        • Local Institution
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2L 5B1
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution
      • Santiago De Chile, Metropolitana, Chile
        • Local Institution
  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Local Institution
  • Costa Rica
    • Barrio Aranjuez
      • San Jose, Barrio Aranjuez, Costa Rica, 1792
        • Local Institution
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Local Institution
  • France
      • Le Kremlin Bicetre, France, 94275
        • Local Institution
      • Lyon Cedex 02, France, 69288
        • Local Institution
      • Paris, France, 75020
        • Local Institution
      • Paris, France, 75014
        • Local Institution
      • Tourcoing, France, 59208
        • Local Institution
  • Guatemala
      • Guatemala, Guatemala
        • Local Institution
      • Guatemala, Guatemala, 01011
        • Local Institution
      • Guatemala, Guatemala, 01016
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1097
        • Local Institution
  • Indonesia
      • Jakarta, Indonesia, 10430
        • Local Institution
  • Italy
      • Milano, Italy, 20127
        • Local Institution
      • Milano, Italy, 20157
        • Local Institution
      • Modena, Italy, 41100
        • Local Institution
      • Roma, Italy, 00185
        • Local Institution
      • Torino, Italy, 10149
        • Local Institution
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Local Institution
      • Kuala Lumpur, Malaysia, 59100
        • Local Institution
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution
      • Mexico, Distrito Federal, Mexico, 03100
        • Local Institution
  • Panama
      • Panama, Panama, 4746
        • Local Institution
  • Peru
      • Lima, Peru, 1
        • Local Institution
      • Lima, Peru, 31
        • Local Institution
      • Lima, Peru, 13
        • Local Institution
      • Lima, Peru, LIMA 14
        • Local Institution
    • Lima
      • Barranco, Lima, Peru, 4
        • Local Institution
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Local Institution
      • Porto, Portugal, 4200-319
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico, Inc.
      • San Juan, Puerto Rico, 00927
        • V.A. Medical Center
  • Russian Federation
      • Moscow, Russian Federation, 111123
        • Local Institution
      • St. Petersburg, Russian Federation, 189635
        • Local Institution
      • St.petersburg, Russian Federation, 193167
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Local Institution
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Local Institution
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2013
        • Local Institution
      • Meadowdale, Gauteng, South Africa, 1610
        • Local Institution
      • Westdene, Gauteng, South Africa, 2092
        • Local Institution
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
        • Local Institution
      • Rugby, Western Cape, South Africa, 7405
        • Local Institution
  • Spain
      • Badalona, Spain, 08915
        • Local Institution
      • Barcelona, Spain, 08036
        • Local Institution
      • Bilbao, Spain, 48013
        • Local Institution
      • Cordoba, Spain, 14004
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
      • Madrid, Spain, 28040
        • Local Institution
      • Madrid, Spain, 28029
        • Local Institution
      • Sevilla, Spain, 41013
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 108
        • Local Institution
  • Thailand
      • Bangkok, Thailand, 10400
        • Local Institution
      • Bangkok, Thailand, 10700
        • Local Institution
      • Bangkok, Thailand, 10300
        • Local Institution
      • Chiangmai, Thailand, 50200
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Body Positive, Inc
    • California
      • Los Angeles, California, United States, 90033
        • Rand Schrader Clinic
      • San Francisco, California, United States, 94109
        • St Francis Memorial Hospital
    • Florida
      • Miami Beach, Florida, United States, 33139
        • Sbma Research, Llc
      • Tampa, Florida, United States, 33607
        • St Josephs Cmprhnsv Rsch Inst
    • Indiana
      • Indianapolis, Indiana, United States, 46218
        • Infectious Disease Of Indiana, Psc
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Univ Of Kansas Sch Of Med
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • CRI of New England
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Jemsek Clinic
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Inf Dis Assoc
      • Houston, Texas, United States, 77098
        • The Schrader Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must provide written informed consent

  • Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is

    ≤ 10,000 copies/mL while on therapy

  • Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor
  • ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)
  • Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study
  • WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
  • All subjects previously discontinued from an atazanavir study for any reason
  • Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
  • Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
  • Any of the following laboratory values:
  • a) Serum creatinine ≥ 1.5 times the upper limit of normal,
  • b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
  • Hypersensitivity to any component of the formulation of study drug
  • Refer to Section 6.4.1 which details all prohibited therapies
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Atazanavir
Drug: Atazanavir
Tablets, Oral, 400 mg, once daily, indefinitely
Other Names:
  • Reyataz
  • BMS-232632
Experimental: Atazanavir/Ritonavir
Drug: Atazanavir/Ritonavir
Tablets, Oral, 300/100 mg, once daily, indefinitely
Other Names:
  • Reyataz
  • BMS-232632
Active Comparator: Lopinavir/Ritonavir
Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Drug: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, once daily, indefinitely
Other Names:
  • Truvada
Drug: Lopinavir/ritonavir
Tablets, Oral, 400/100 mg, twice daily, indefinitely

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
Time Frame: Date of First Dose to 30 days post the last dose; approximately 405 weeks)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
Date of First Dose to 30 days post the last dose; approximately 405 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI424-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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