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Completed

NCT Number: NCT00293254

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir potassium

Drug

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

Other names: ISENTRESS™

Comparator: placebo

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16

    Time frame: 16 Weeks

    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16

  2. Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48

    Time frame: 48 Weeks

    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48

  3. Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL

    Time frame: 156 Weeks

    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156

  4. Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL

    Time frame: 240 Weeks

    Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240

  5. Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response

    Time frame: 156 Weeks

    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).

  6. Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16

    Time frame: Baseline and Week 16

    Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)

  7. Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48

    Time frame: Baseline and Week 48

    Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)

  8. Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)

    Time frame: Baseline and Week 156

    Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)

  9. Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)

    Time frame: Baseline and Week 240

    Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)

  10. Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16

    Time frame: Baseline and Week 16

    Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)

  11. Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48

    Time frame: Baseline and Week 48

    Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)

  12. Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)

    Time frame: Baseline and Week 156

    Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)

  13. Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)

    Time frame: Baseline and Week 240

    Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2011
First posted
Feb 17, 2006
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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