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Completed

NCT Number: NCT00100048

A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)

This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.

Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.

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 who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)

Extension Studies:

  • First extension: Patient completed the 48-week base study
  • Second extension: Patient completed the first 144-week extension study

Exclusion criteria

  • Less than 18 years of age
  • Individuals who currently do not test positive for HIV

Treatment and study plan

Comparator: MK0518 monotherapy

Drug

MK0518 twice daily for 10 days

Comparator: MK0518 combination therapy

Drug

MK0518 twice daily for 48 weeks

Comparator: efavirenz

Drug

efavirenz 600 mg every night at bedtime for 48 weeks

Comparator: tenofovir

Drug

tenofovir 300 mg daily for 48 weeks

Comparator: lamivudine

Drug

lamivudine 300 mg daily for 48 weeks

placebo monotherapy

Drug

Placebo to MK0518 twice daily

Primary outcomes

  1. Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)

    Time frame: Baseline and Day 10

    Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)

  2. Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)

    Time frame: 10 days

    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

    Serious CAEs are any AEs occurring at any dose that; Results

    in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or

    prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an

    overdose.

  3. Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)

    Time frame: Week 24

  4. Number of Patients With Clinical Adverse Experiences (CAEs)

    Time frame: 48 weeks

    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

  5. Number of Patients With Serious CAEs (Cohort I and II Combined)

    Time frame: 48 weeks

    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

  6. Number of Patients With Serious CAEs and Non-serious CAEs at Week 144

    Time frame: 144 Weeks

    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

  7. Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)

    Time frame: Week 240

    An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.

    A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose.

  8. Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240

    Time frame: Week 240

    HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.

Secondary outcomes

  1. Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)

    Time frame: Week 24

  2. Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)

    Time frame: Baseline and Week 24

    Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)

  3. Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)

    Time frame: Baseline and Week 24

    Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)

  4. Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96

    Time frame: 96 Weeks

  5. Change From Baseline in Plasma HIV RNA at Week 96

    Time frame: Baseline and Week 96

  6. Change From Baseline in CD4 Cell Count at Week 96

    Time frame: Baseline and Week 96

  7. Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240

    Time frame: Week 240

    HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.

  8. Change From Baseline in Plasma HIV RNA at Week 240

    Time frame: Baseline and Week 240

    HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.

  9. Change From Baseline in CD4 (T-helper) Cell Count at Week 240

    Time frame: Baseline and Week 240

    Change in number of CD4 cells/mm^3 from baseline to Week 240.

Other outcomes

  1. Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48

    Time frame: 48 weeks

  2. Number of Patients With Drug-related CAEs

    Time frame: 48 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs

  3. Number of Patients With Serious Drug-related CAEs

    Time frame: 48 Weeks

    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

  4. Number of Patients That Discontinued With CAEs

    Time frame: 48 Weeks

  5. Number of Patients With Laboratory Adverse Experiences (LAEs)

    Time frame: 48 Weeks

    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

  6. Number of Patients With Serious LAEs

    Time frame: 48 Weeks

    Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

  7. Number of Patients With Drug-related LAEs

    Time frame: 48 Weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs

  8. Number of Patients With Serious Drug-related LAEs

    Time frame: 48 Weeks

    Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

  9. Number of Patients That Discontinued With LAEs

    Time frame: 48 Weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients

Important dates

Study start
2005
Primary completion
2006
Study completion
2010
First posted
Dec 23, 2004
Registry last updated
Sep 9, 2015

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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