A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00100048 |
Recruitment Status
:
Completed
First Posted
: December 23, 2004
Results First Posted
: March 29, 2010
Last Update Posted
: September 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Acquired Immunodeficiency Syndrome | Drug: Comparator: MK0518 monotherapy Drug: Comparator: MK0518 combination therapy Drug: Comparator: efavirenz Drug: Comparator: tenofovir Drug: Comparator: lamivudine Drug: Placebo monotherapy | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 206 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 600 mg monotherapy
MK0518 600 mg twice daily
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Drug: Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
|
Experimental: 400 mg monotherapy
MK0518 400 mg twice daily
|
Drug: Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
|
Experimental: 200 mg monotherapy
MK0518 200 mg twice daily
|
Drug: Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
|
Experimental: 100 mg monotherapy
MK0518 100 mg twice daily
|
Drug: Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
|
Placebo Comparator: placebo monotherapy
Placebo to MK0518 twice daily
|
Drug: Placebo monotherapy
Placebo to MK0518 twice daily
|
Experimental: 600 mg combo therapy
MK0518 600 mg + tenofovir + lamivudine
|
Drug: Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Drug: Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Drug: Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
|
Experimental: 400 mg combo therapy
MK0518 400 mg + tenofovir + lamivudine
|
Drug: Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Drug: Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Drug: Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
|
Experimental: 200 mg combo therapy
MK0518 200 mg + tenofovir + lamivudine
|
Drug: Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Drug: Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Drug: Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
|
Experimental: 100 mg combo therapy
MK0518 100 mg + tenofovir + lamivudine
|
Drug: Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Drug: Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Drug: Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
|
Active Comparator: EFV combo therapy
efavirenz + tenofovir + lamivudine
|
Drug: Comparator: efavirenz
efavirenz 600 mg every night at bedtime for 48 weeks
Drug: Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Drug: Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
|
- 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)
- 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.
- Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) [ Time Frame: Week 24 ]
- 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.
- 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
- 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
- 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.
- 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.
- Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) [ Time Frame: Week 24 ]
- 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)
- 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)
- 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 ]
- Change From Baseline in Plasma HIV RNA at Week 96 [ Time Frame: Baseline and Week 96 ]
- Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ]
- 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.
- 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.
- 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.
- Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ]
- 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
- 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.
- Number of Patients That Discontinued With CAEs [ Time Frame: 48 Weeks ]
- 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
- 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
- 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
- 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
- Number of Patients That Discontinued With LAEs [ Time Frame: 48 Weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100048
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications:
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00100048 History of Changes |
Other Study ID Numbers: |
0518-004 2004_096 |
First Posted: | December 23, 2004 Key Record Dates |
Results First Posted: | March 29, 2010 |
Last Update Posted: | September 9, 2015 |
Last Verified: | September 2015 |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Tenofovir Lamivudine Efavirenz Raltegravir Potassium |
Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers HIV Integrase Inhibitors |