A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

NCT00293254 | Completed Phase 3 Results

• 2 other identifiers: 0518-0192005_097
• Study Type: interventional
• Target: 351
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16

  Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 16

  16 Weeks

• Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48

  Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 48

  48 Weeks

• Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL

  Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 156

  156 Weeks

• Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL

  Percentage of participants who achieved HIV RNA \<400 Copies/mL at Week 240

  240 Weeks

Secondary Outcomes (13)

• Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16

  16 Weeks

• Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48

  48 Weeks

• Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL

  156 Weeks

• Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL

  240 Weeks

• Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response

  156 Weeks

Study Arms (2)

1

EXPERIMENTAL

raltegravir potassium

Drug: raltegravir potassium

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo

Interventions

raltegravir potassium DRUG

Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.

Also known as: ISENTRESS™

1

Comparator: placebo DRUG

Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

2

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:

• Patient must be HIV positive with HIV RNA values that are within ranges required by the study
• Patient must have documented failure of certain antiretroviral therapy
• Patient must be on the same antiretroviral therapy for at least the past two months

You may not qualify if:

• Patient less than 16 years old
• Additional study criteria will be discussed and identified by the study doctor

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (3)

• Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975.

  PMID: 18650512 BACKGROUND

• Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978.

  PMID: 18650513 BACKGROUND

• Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.

  PMID: 20085491 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 17, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2011
• Last Updated: March 21, 2017
• Results First Posted: September 30, 2009

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share