Trials Sponsors Conditions Drugs Pricing

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
+8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

raltegravir potassium

Drug: raltegravir potassium

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo

Interventions

raltegravir potassiumDrug

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™

Comparator: placeboDrug

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

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (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

Sponsors & Collaborators

Merck Sharp & Dohme LLC
Industrylead

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: 18650512BACKGROUND
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

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency Syndromes

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

Study Officials

Medical Monitor
Merck Sharp & Dohme LLC
STUDY DIRECTOR

Publication Agreements

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

Enrollment

351 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (13)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (13)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record