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

NCT01003990 | Completed Phase 3 Results

• 1 other identifier: AI424-077
• Study Type: interventional
• Target: 710
• Locations: 24 countries
• Sites: 87

Brief Summary

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.

Conditions

HIV

Keywords

Treatment experienced

Outcome Measures

Primary Outcomes (1)

• 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

  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)

Study Arms (3)

Atazanavir

EXPERIMENTAL

Drug: Atazanavir

Atazanavir/Ritonavir

EXPERIMENTAL

Drug: Atazanavir/Ritonavir

Lopinavir/Ritonavir

ACTIVE COMPARATOR

Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Drug: Tenofovir/Emtricitabine; Drug: Lopinavir/ritonavir

Interventions

Atazanavir DRUG

Tablets, Oral, 400 mg, once daily, indefinitely

Also known as: Reyataz, BMS-232632

Atazanavir

Atazanavir/Ritonavir DRUG

Tablets, Oral, 300/100 mg, once daily, indefinitely

Also known as: Reyataz, BMS-232632

Atazanavir/Ritonavir

Tenofovir/Emtricitabine DRUG

Tablets, Oral, 300/200 mg, once daily, indefinitely

Also known as: Truvada

Lopinavir/Ritonavir

Lopinavir/ritonavir DRUG

Tablets, Oral, 400/100 mg, twice daily, indefinitely

Lopinavir/Ritonavir

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (88)

Phoenix Body Positive, Inc

Phoenix, Arizona, 85006, United States

Location

Rand Schrader Clinic

Los Angeles, California, 90033, United States

Location

St Francis Memorial Hospital

San Francisco, California, 94109, United States

Location

Sbma Research, Llc

Miami Beach, Florida, 33139, United States

Location

St Josephs Cmprhnsv Rsch Inst

Tampa, Florida, 33607, United States

Location

Infectious Disease Of Indiana, Psc

Indianapolis, Indiana, 46218, United States

Location

Univ Of Kansas Sch Of Med

Wichita, Kansas, 67214, United States

Location

Cri Of New England

Boston, Massachusetts, 02215, United States

Location

University Of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Jemsek Clinic

Huntersville, North Carolina, 28078, United States

Location

Tarrant County Inf Dis Assoc

Fort Worth, Texas, 76104, United States

Location

The Schrader Clinic

Houston, Texas, 77098, United States

Location

Local Institution

Buenos Aires, Buenos Aires, 1155, Argentina

Location

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Buenos Aires, Buenos Aires, 1181, Argentina

Location

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Buenos Aires, Buenos Aires, 1202, Argentina

Location

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Buenos Aires, Buenos Aires, 1650, Argentina

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Córdoba, Córdoba Province, X5000BJH, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Curitiba, Paraná, 80060, Brazil

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Curitiba, Paraná, 80240, Brazil

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Recife, Pernambuco, 52052, Brazil

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Rio de Janeiro, Rio de Janeiro, 21040000, Brazil

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Rio de Janeiro - Rj, Rio de Janeiro, 22271, Brazil

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Campinas, São Paulo, 13083, Brazil

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Sao Paulo - Sp, São Paulo, 01246, Brazil

Location

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São Paulo, São Paulo, 01246, Brazil

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Hamilton, Ontario, L8S 4J9, Canada

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Montreal, Quebec, H2L 5B1, Canada

Location

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Santiago, Santiago Metropolitan, Chile

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Bogota, Cundinamarca, Colombia

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San José, Barrio Aranjuez, 1792, Costa Rica

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Santo Domingo, Dominican Republic

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Le Kremlin-Bicêtre, 94275, France

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Lyon, 69288, France

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Paris, 75014, France

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Paris, 75020, France

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Tourcoing, 59208, France

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Guatemala City, 01011, Guatemala

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Guatemala City, 01016, Guatemala

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Guatemala City, Guatemala

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Budapest, 1097, Hungary

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Jakarta, 10430, Indonesia

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Milan, 20127, Italy

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Milan, 20157, Italy

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Modena, 41100, Italy

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Roma, 00185, Italy

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Torino, 10149, Italy

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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

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Mexico City, Mexico City, 03100, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Panama City, 4746, Panama

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Lima, Lima Province, 13, Peru

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Lima, Lima Province, 1, Peru

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Lima, Lima Province, 31, Peru

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Lima, Lima Province, LIMA 14, Peru

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Barranco, Lima region, 4, Peru

Location

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Lisbon, 1649-035, Portugal

Location

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Porto, 4200-319, Portugal

Location

Clinical Research Puerto Rico, Inc.

San Juan, 00909, Puerto Rico

Location

V.A. Medical Center

San Juan, 00927, Puerto Rico

Location

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Moscow, 111123, Russia

Location

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Saint Petersburg, 189635, Russia

Location

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Saint Petersburg, 193167, Russia

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Singapore, 308433, Singapore

Location

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Bloemfontein, Free State, 9301, South Africa

Location

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Johannesburg, Gauteng, 2013, South Africa

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Meadowdale, Gauteng, 1610, South Africa

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Westdene, Gauteng, 2092, South Africa

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Observatory, Western Cape, 7925, South Africa

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Rugby, Western Cape, 7405, South Africa

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Badalona, 08915, Spain

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Barcelona, 08036, Spain

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Bilbao, 48013, Spain

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Córdoba, 14004, Spain

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Madrid, 28029, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Seville, 41013, Spain

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Kaohsiung City, 813, Taiwan

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Taipei, 100, Taiwan

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Taipei, 108, Taiwan

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Bangkok, 10300, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Atazanavir Sulfate; atazanavir, ritonavir drug combination; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Pyrimidinones

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2002
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-04

Locations

FR (5); CA (2); MY (2); CL (1); US (12); PA (1); BR (8); DO (1); HU (1); ME (2); GU (3); PE (5); PR (2); RU (3); CO (1); SG (1); ZA (7); ES (9); TW (3); PT (2); TH (4); AR (6); ID (1); IT (5)