HIVPhase 3NCT01003990

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

A Phase 3 study testing Atazanavir, Atazanavir/Ritonavir and Tenofovir/Emtricitabine in people with HIV, run by Bristol-Myers Squibb at 88 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV
What is being tested?: Atazanavir, Atazanavir/Ritonavir and Tenofovir/Emtricitabine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 710 participants
Where: 88 sitesin 25 countries
Study dates: Oct 2002to Feb 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

88 sites in 25 countries.

Country

City, postcode or hospital

88 sites in 25 countries

United States12 sites

Cri Of New England
Boston, Massachusetts, 02215
Tarrant County Inf Dis Assoc
Fort Worth, Texas, 76104
The Schrader Clinic
Houston, Texas, 77098
Jemsek Clinic
Huntersville, North Carolina, 28078
Infectious Disease Of Indiana, Psc
Indianapolis, Indiana, 46218
Rand Schrader Clinic
Los Angeles, California, 90033
Sbma Research, Llc
Miami Beach, Florida, 33139
University Of Nebraska Medical Center
Omaha, Nebraska, 68198
Phoenix Body Positive, Inc
Phoenix, Arizona, 85006
St Francis Memorial Hospital
San Francisco, California, 94109
St Josephs Cmprhnsv Rsch Inst
Tampa, Florida, 33607
Univ Of Kansas Sch Of Med
Wichita, Kansas, 67214

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Spain9 sites

Local Institution
Badalona, 08915
Local Institution
Barcelona, 08036
Local Institution
Bilbao, 48013
Local Institution
Córdoba, 14004
Local Institution
Madrid, 28029
Local Institution
Madrid, 28034
Local Institution
Madrid, 28040
Local Institution
Madrid, 28046
Local Institution
Seville, 41013

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Brazil8 sites

Local Institution
Campinas, São Paulo, 13083
Local Institution
Curitiba, Paraná, 80060
Local Institution
Curitiba, Paraná, 80240
Local Institution
Recife, Pernambuco, 52052
Local Institution
Rio de Janeiro, Rio de Janeiro, 21040000
Local Institution
Rio de Janeiro - Rj, Rio de Janeiro, 22271
Local Institution
São Paulo, São Paulo, 01246
Local Institution
Sao Paulo - Sp, São Paulo, 01246

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South Africa7 sites

Local Institution
Bloemfontein, Free State, 9301
Local Institution
Johannesburg, Gauteng, 2013
Local Institution
Meadowdale, Gauteng, 1610
Local Institution
Observatory, Western Cape, 7925
Local Institution
Port Elizabeth, Eastern Cape, 6001
Local Institution
Rugby, Western Cape, 7405
Local Institution
Westdene, Gauteng, 2092

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Argentina6 sites

Local Institution
Buenos Aires, Buenos Aires, 1155
Local Institution
Buenos Aires, Buenos Aires, 1181
Local Institution
Buenos Aires, Buenos Aires, 1202
Local Institution
Buenos Aires, Buenos Aires, 1650
Local Institution
Córdoba, Córdoba Province, X5000BJH
Local Institution
Rosario, Santa Fe Province, 2000

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France5 sites

Local Institution
Le Kremlin-Bicêtre, 94275
Local Institution
Lyon, 69288
Local Institution
Paris, 75014
Local Institution
Paris, 75020
Local Institution
Tourcoing, 59208

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Italy5 sites

Local Institution
Milan, 20127
Local Institution
Milan, 20157
Local Institution
Modena, 41100
Local Institution
Roma, 00185
Local Institution
Torino, 10149

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Peru5 sites

Local Institution
Barranco, Lima region, 4
Local Institution
Lima, Lima Province, 13
Local Institution
Lima, Lima Province, 1
Local Institution
Lima, Lima Province, 31
Local Institution
Lima, Lima Province, LIMA 14

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Thailand4 sites

Local Institution
Bangkok, 10300
Local Institution
Bangkok, 10400
Local Institution
Bangkok, 10700
Local Institution
Chiang Mai, 50200

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Guatemala3 sites

Local Institution
Guatemala City, 01011
Local Institution
Guatemala City, 01016
Local Institution
Guatemala City

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Russia3 sites

Local Institution
Moscow, 111123
Local Institution
Saint Petersburg, 189635
Local Institution
Saint Petersburg, 193167

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Taiwan3 sites

Local Institution
Kaohsiung City, 813
Local Institution
Taipei, 100
Local Institution
Taipei, 108

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Canada2 sites

Local Institution
Hamilton, Ontario, L8S 4J9
Local Institution
Montreal, Quebec, H2L 5B1

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Malaysia2 sites

Local Institution
Kuala Lumpur, Kuala Lumpur, 50586
Local Institution
Kuala Lumpur, Kuala Lumpur, 59100

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Mexico2 sites

Local Institution
Mexico City, Mexico City, 03100
Local Institution
Mexico City, Mexico City, 14080

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Portugal2 sites

Local Institution
Lisbon, 1649-035
Local Institution
Porto, 4200-319

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Puerto Rico2 sites

Clinical Research Puerto Rico, Inc.
San Juan, 00909
V.A. Medical Center
San Juan, 00927

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Chile1 site

Local Institution
Santiago, Santiago Metropolitan

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Colombia1 site

Local Institution
Bogota, Cundinamarca

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Costa Rica1 site

Local Institution
San José, Barrio Aranjuez, 1792

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Dominican Republic1 site

Local Institution
Santo Domingo

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Hungary1 site

Local Institution
Budapest, 1097

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Indonesia1 site

Local Institution
Jakarta, 10430

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Panama1 site

Local Institution
Panama City, 4746

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Singapore1 site

Local Institution
Singapore, 308433

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About this study

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

Read the detailed description

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

Conditions: HIV
Being tested: Atazanavir, Atazanavir/Ritonavir, Tenofovir/Emtricitabine, Lopinavir/ritonavir
Keywords: Treatment experienced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtazanavirDrug
Also called Reyataz, BMS-232632
Tablets, Oral, 400 mg, once daily, indefinitely
Atazanavir/RitonavirDrug
Also called Reyataz, BMS-232632
Tablets, Oral, 300/100 mg, once daily, indefinitely
Tenofovir/EmtricitabineDrug
Also called Truvada
Tablets, Oral, 300/200 mg, once daily, indefinitely
Lopinavir/ritonavirDrug
Tablets, Oral, 400/100 mg, twice daily, indefinitely

Study groups in NCT01003990
Study group	Role	What they receive
Atazanavir	Experimental	Not described Receives: Drug: Atazanavir
Atazanavir/Ritonavir	Experimental	Not described Receives: 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). Receives: Drug: Tenofovir/Emtricitabine; Drug: Lopinavir/ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Date of First Dose to 30 days post the last dose; approximately 405 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Feb 2016

First posted29 Oct 2009 (estimated)
Study startOct 2002
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 710 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01003990
Sponsor's protocol ID: AI424-077
Status last verified: Apr 2017
First submitted: 20 Oct 2009
Last updated: 11 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study
ClinicalTrials.gov ID: NCT01003990
Acronym / sponsor ID: AI424-077
Conditions: HIV
Keywords: Treatment experienced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 710 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 29 Oct 2009 (estimated)
Results: Posted 11 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Atazanavir	Experimental	Drug: Atazanavir
Atazanavir/Ritonavir	Experimental	Drug: Atazanavir/Ritonavir
Lopinavir/Ritonavir	Active comparator	Drug: Tenofovir/Emtricitabine, Drug: Lopinavir/ritonavirRitonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtazanavirAlso: Reyataz, BMS-232632Tablets, Oral, 400 mg, once daily, indefinitely	Drug	Atazanavir
Atazanavir/RitonavirAlso: Reyataz, BMS-232632Tablets, Oral, 300/100 mg, once daily, indefinitely	Drug	Atazanavir/Ritonavir
Tenofovir/EmtricitabineAlso: TruvadaTablets, Oral, 300/200 mg, once daily, indefinitely	Drug	Lopinavir/Ritonavir
Lopinavir/ritonavirTablets, Oral, 400/100 mg, twice daily, indefinitely	Drug	Lopinavir/Ritonavir

Primary outcome

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.

Results and safety

Results posted to the registry on 11 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atazanavir (ATV)	459	367
Atazanavir/Ritonavir (ATV/RTV)	154	103
Lopinavir/Ritonavir (LPV/RTV)	96	53

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Atazanavir (ATV) n = 459	Atazanavir/Ritonavir (ATV/RTV) n = 154	Lopinavir/Ritonavir (LPV/RTV) n = 96
SAEs	35	19	12
Treatment Related SAEs	4	1	0
Treatment Related AEs of Any Grade	180	49	34
AEs Leading to Discontinuation of Study Therapy	8	5	11
Grade 3 to Grade 4 AEs	72	27	15
Grade 2 to Grade 4 AEs	102	28	19
CDC Class C AIDS Events	2	0	0
Deaths	2	7	1

Population analysed: All Treated Participants

Adverse events

Time frame: Date of first dose to date of last dose plus 30 days; approx. 680 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atazanavir (ATV)	35 of 459 (7.6%)	284 of 459 (61.9%)	2 of 459
Atazanavir/Ritonavir (ATV/RTV)	19 of 154 (12.3%)	92 of 154 (59.7%)	7 of 154
Lopinavir/Ritonavir (LPV/RTV)	12 of 96 (12.5%)	57 of 96 (59.4%)	1 of 96

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

88 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atazanavir, Atazanavir/Ritonavir and Tenofovir/Emtricitabine in people with HIV, run by Bristol-Myers Squibb at 88 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Spain, Brazil, South Africa, Argentina and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01003990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.