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

HIV Infections Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293254
• Other study ID #: 0518-019
• Secondary ID: 2005_097
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2006
• Last updated: July 16, 2015
• Start date: February 2006
• Est. completion date: May 2011

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: May 2011
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient less than 16 years old

• Additional study criteria will be discussed and identified by the study doctor

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• raltegravir potassium
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
• Comparator: placebo
Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (3)

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. — View Citation

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. — View Citation

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16	Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16	16 Weeks	No
Secondary	Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48	Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48	48 Weeks	No
Secondary	Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL	Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156	156 Weeks	No
Secondary	Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL	Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240	240 Weeks	No
Secondary	Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response	For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).	156 Weeks	No
Secondary	Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16	Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)	Baseline and Week 16	No
Secondary	Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48	Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)	Baseline and Week 48	No
Secondary	Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)	Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)	Baseline and Week 156	No
Secondary	Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)	Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)	Baseline and Week 240	No
Secondary	Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16	Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)	Baseline and Week 16	No
Secondary	Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48	Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)	Baseline and Week 48	No
Secondary	Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)	Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)	Baseline and Week 156	No
Secondary	Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)	Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)	Baseline and Week 240	No