A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

NCT00745823 | Terminated Phase 3 Results DMC

• 3 other identifiers: 0518-0712008_543CTRI/2009/091/000145
• Study Type: interventional
• Target: 775
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Conditions

HIV

Keywords

HIV Infections; Treatment Naïve

Outcome Measures

Primary Outcomes (3)

• Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks

  Week 48

• Number of Participants With One or More Adverse Events at 48 Weeks

  Week 48

• Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks

  Week 48

Secondary Outcomes (7)

• Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks

  48 weeks

• Mean Change From Baseline to Week 48 in CD4 Cell Count

  Baseline and Week 48

• Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks

  Week 96

• Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks

  Week 96

• Mean Change From Baseline to Week 96 in CD4 Cell Count

  Baseline and Week 96

Study Arms (2)

Raltegravir 400 mg b.i.d.

ACTIVE COMPARATOR

Drug: Comparator: Raltegravir 400 mg b.i.d.; Drug: TRUVADA™

Raltegravir 800 mg q.d.

EXPERIMENTAL

Drug: Experimental: Raltegravir 800 mg q.d.; Drug: TRUVADA™

Interventions

Comparator: Raltegravir 400 mg b.i.d. DRUG

Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)

Also known as: ISENTRESS™

Raltegravir 400 mg b.i.d.

Experimental: Raltegravir 800 mg q.d. DRUG

Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.

Also known as: ISENTRESS™

Raltegravir 800 mg q.d.

TRUVADA™ DRUG

One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)

Raltegravir 400 mg b.i.d.; Raltegravir 800 mg q.d.

Eligibility Criteria

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

You may qualify if:

• Patient is male or female 18 years of age or older
• Patient is HIV positive
• Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART
• Extension Study:
• The planned extension study did not take place as the study was terminated after the Week 48 analysis.

You may not qualify if:

• Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
• Patient has documented resistance to tenofovir or emtricitabine
• Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
• Patient is pregnant or breastfeeding, or expecting to conceive

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Eron JJ Jr, Rockstroh JK, Reynes J, Andrade-Villanueva J, Ramalho-Madruga JV, Bekker LG, Young B, Katlama C, Gatell-Artigas JM, Arribas JR, Nelson M, Campbell H, Zhao J, Rodgers AJ, Rizk ML, Wenning L, Miller MD, Hazuda D, DiNubile MJ, Leavitt R, Isaacs R, Robertson MN, Sklar P, Nguyen BY; QDMRK Investigators. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial. Lancet Infect Dis. 2011 Dec;11(12):907-15. doi: 10.1016/S1473-3099(11)70196-7. Epub 2011 Sep 18.

  PMID: 21933752 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

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; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

The study was terminated before the 96-week efficacy analysis. Adverse event data were collected for the entire treatment period up to a maximum of Week 108, which defines the Overall Study period.

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: September 2, 2008
• First Posted: September 3, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: May 1, 2011
• Last Updated: March 21, 2017
• Results First Posted: April 25, 2012

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share