---
title: A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
nct_id: NCT00293254
overall_status: COMPLETED
phase: PHASE3
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: HIV Infections
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00293254.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00293254"
ct_last_update_post_date: 2017-03-21
last_seen_at: "2026-05-12T06:21:08.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

**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

**NCT ID:** [NCT00293254](https://clinicaltrials.gov/study/NCT00293254)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 351
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** HIV Infections
- **Start Date:** 2006-02
- **Completion Date:** 2011-05
- **CT.gov Last Update:** 2017-03-21

## 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **1** (EXPERIMENTAL) — raltegravir potassium
- **2** (PLACEBO_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.
- **Comparator: placebo** (DRUG) — Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

## Primary Outcomes

- **Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16** _(time frame: 16 Weeks)_ — Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 16
- **Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48** _(time frame: 48 Weeks)_ — Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 48
- **Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL** _(time frame: 156 Weeks)_ — Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 156
- **Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL** _(time frame: 240 Weeks)_ — Percentage of participants who achieved HIV RNA \<400 Copies/mL at Week 240

## Secondary Outcomes

- **Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16** _(time frame: 16 Weeks)_
- **Percentage of Participants Achieving 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** _(time frame: 156 Weeks)_
- **Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL** _(time frame: 240 Weeks)_
- **Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response** _(time frame: 156 Weeks)_
- **Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16** _(time frame: Baseline and Week 16)_
- **Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48** _(time frame: Baseline and Week 48)_
- **Double-Blind Extension - Week 156: Change From Baseline 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)** _(time frame: Baseline and Week 240)_
- **Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16** _(time frame: Baseline and Week 16)_
- **Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48** _(time frame: Baseline and Week 48)_
- **Double-Blind Extension - Week 156: Change From Baseline 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)** _(time frame: Baseline and Week 240)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00293254.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00293254*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*