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HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

NCT ID: NCT01384734

Last Updated: 2018-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-26

Study Completion Date

2017-05-12

Brief Summary

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The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

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Detailed Description

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Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.

Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)

Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir

Treatment Group 1

Group Type EXPERIMENTAL

BMS-663068 400 mg

Intervention Type DRUG

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Raltegravir 400 mg

Intervention Type DRUG

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Tenofovir 300 mg

Intervention Type DRUG

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir

Treatment Group 2

Group Type EXPERIMENTAL

BMS-663068 800 mg

Intervention Type DRUG

Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Raltegravir 400 mg

Intervention Type DRUG

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Tenofovir 300 mg

Intervention Type DRUG

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir

Treatment Group 3

Group Type EXPERIMENTAL

BMS-663068 600 mg

Intervention Type DRUG

Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Raltegravir 400 mg

Intervention Type DRUG

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Tenofovir 300 mg

Intervention Type DRUG

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir

Treatment Group 4

Group Type EXPERIMENTAL

BMS-663068 1200 mg

Intervention Type DRUG

Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Raltegravir 400 mg

Intervention Type DRUG

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Tenofovir 300 mg

Intervention Type DRUG

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir

Treatment Group 1 (reference arm)

Group Type ACTIVE_COMPARATOR

Raltegravir 400 mg

Intervention Type DRUG

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Tenofovir 300 mg

Intervention Type DRUG

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Ritonavir 100 mg

Intervention Type DRUG

Tablets, Oral, 100 mg, Once daily, 96 weeks

Atazanavir 300 mg

Intervention Type DRUG

Capsules, Oral, 300 mg, Once daily, 96 weeks

Interventions

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BMS-663068 400 mg

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type DRUG

BMS-663068 800 mg

Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type DRUG

BMS-663068 600 mg

Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type DRUG

BMS-663068 1200 mg

Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type DRUG

Raltegravir 400 mg

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type DRUG

Tenofovir 300 mg

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type DRUG

Ritonavir 100 mg

Tablets, Oral, 100 mg, Once daily, 96 weeks

Intervention Type DRUG

Atazanavir 300 mg

Capsules, Oral, 300 mg, Once daily, 96 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
* Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
* Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 \< 0.1 μM
* Cluster of differentiation (CD)4+ T-cell count \> 50 cells/mm3

Exclusion Criteria

* History (or evidence at Screening) of genotypic resistance to any component of the study regimen \[ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)\]
* Certain laboratory and electrocardiogram (ECG) values
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Washington D.C., District of Columbia, United States

Site Status

GSK Investigational Site

Coral Gables, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

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GSK Investigational Site

Atlanta, Georgia, United States

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GSK Investigational Site

New York, New York, United States

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GSK Investigational Site

Durham, North Carolina, United States

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GSK Investigational Site

Cincinnati, Ohio, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, United States

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GSK Investigational Site

Austin, Texas, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Longview, Texas, United States

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GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

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GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

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GSK Investigational Site

Córdoba, , Argentina

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GSK Investigational Site

Rosario, , Argentina

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GSK Investigational Site

Bogotá, , Colombia

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GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Hamburg, , Germany

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GSK Investigational Site

München, , Germany

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GSK Investigational Site

Guadalajara, Jalisco, Mexico

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GSK Investigational Site

Zapopan, Jalisco, Mexico

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GSK Investigational Site

San Luis Potosí City, San Luis Potosí, Mexico

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GSK Investigational Site

Aguascalientes, , Mexico

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GSK Investigational Site

DF, , Mexico

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GSK Investigational Site

Distrito Federal, , Mexico

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GSK Investigational Site

Mexico City, , Mexico

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GSK Investigational Site

Iquitos, Loreto, Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Bucharest, , Romania

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GSK Investigational Site

Constanța, , Romania

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GSK Investigational Site

Craiova, , Romania

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GSK Investigational Site

Iași, , Romania

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Smolensk, , Russia

Site Status

GSK Investigational Site

Dundee, KwaZulu-Natal, South Africa

Site Status

GSK Investigational Site

Durban, , South Africa

Site Status

GSK Investigational Site

Johannesburg, , South Africa

Site Status

GSK Investigational Site

Observatory, Cape Town, , South Africa

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Córdoba, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

Countries

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United States Argentina Colombia Germany Mexico Peru Romania Russia South Africa Spain

References

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Thompson M, Lalezari JP, Kaplan R, Pinedo Y, Pena OAS, Cahn P, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther. 2017;22(3):215-223. doi: 10.3851/IMP3112. Epub 2016 Dec 6.

Reference Type DERIVED
PMID: 27922453 (View on PubMed)

Landry I, Zhu L, Abu Tarif M, Hruska M, Sadler BM, Pitsiu M, Joshi S, Hanna GJ, Lataillade M, Boulton DW, Bertz RJ. Model-Based Phase 3 Dose Selection for HIV-1 Attachment Inhibitor Prodrug BMS-663068 in HIV-1-Infected Patients: Population Pharmacokinetics/Pharmacodynamics of the Active Moiety, BMS-626529. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2782-9. doi: 10.1128/AAC.02503-15. Print 2016 May.

Reference Type DERIVED
PMID: 26902761 (View on PubMed)

Lalezari JP, Latiff GH, Brinson C, Echevarria J, Trevino-Perez S, Bogner JR, Thompson M, Fourie J, Sussmann Pena OA, Mendo Urbina FC, Martins M, Diaconescu IG, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. Lancet HIV. 2015 Oct;2(10):e427-37. doi: 10.1016/S2352-3018(15)00177-0. Epub 2015 Sep 1.

Reference Type DERIVED
PMID: 26423650 (View on PubMed)

Zhou N, Nowicka-Sans B, McAuliffe B, Ray N, Eggers B, Fang H, Fan L, Healy M, Langley DR, Hwang C, Lataillade M, Hanna GJ, Krystal M. Genotypic correlates of susceptibility to HIV-1 attachment inhibitor BMS-626529, the active agent of the prodrug BMS-663068. J Antimicrob Chemother. 2014 Mar;69(3):573-81. doi: 10.1093/jac/dkt412. Epub 2013 Oct 14.

Reference Type DERIVED
PMID: 24128669 (View on PubMed)

Other Identifiers

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AI438-011

Identifier Type: OTHER

Identifier Source: secondary_id

205889

Identifier Type: -

Identifier Source: org_study_id

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