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

Merck Sharp & Dohme LLC351 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

351

Conditions

HIV Infections

Interventions

raltegravir potassiumDRUG

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

Comparator: placeboDRUG

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 240 Weeks

Secondary Outcomes

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

Time frame: 16 Weeks

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

Time frame: 48 Weeks

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

Time frame: 156 Weeks

Data from ClinicalTrials.gov

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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

Time frame: 240 Weeks

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).

Time frame: 156 Weeks

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)

Time frame: Baseline and Week 16

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)

Time frame: Baseline and Week 48

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)

Time frame: Baseline and Week 156

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)

Time frame: Baseline and Week 240

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)

Time frame: Baseline and Week 16

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)

Time frame: Baseline and Week 48

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)

Time frame: Baseline and Week 156

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)

Time frame: Baseline and Week 240