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OpenTrials
Completed

NCT Number: NCT00764946

A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is HIV positive
  • Patient agrees to use (or have their partner use) birth control as defined by the study doctor

Exclusion criteria

  • If female, pregnant or breastfeeding
  • Patient has used an investigational agent in the last 30 days
  • Patient has acute hepatitis
  • Patient has received MK0518 (raltegravir) before
  • Patient has used another experimental HIV-integrase inhibitor

Treatment and study plan

Comparator: raltegravir

Drug

400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Other names: ISENTRESS

Primary outcomes

  1. Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

    Time frame: Week 48

    Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.

  2. Number of Participants With One or More Adverse Events

    Time frame: Week 48

    Numbers of participants with one or more adverse events were summarized by race.

  3. Number of Participants Who Discontinued Due to an Adverse Event

    Time frame: Week 48

    Numbers of participants who discontinued due to an adverse event were summarized by race.

Secondary outcomes

  1. Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48

    Time frame: Week 48

    Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.

  2. Mean Change From Baseline to Week 48 in HIV RNA

    Time frame: Baseline and Week 48

    Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.

  3. Mean Change From Baseline to Week 48 in CD4 Cell Count

    Time frame: Baseline and Week 48

    Mean changes from baseline in CD4 cell counts were summarized by race at each time point.

  4. Number of Participants Without Loss of Virologic Response

    Time frame: Week 48

    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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 2, 2008
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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