HIV InfectionsPhase 2NCT00100048

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

A Phase 2 study testing Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy and Comparator: efavirenz in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Acquired Immunodeficiency Syndrome
What is being tested?: Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy and Comparator: efavirenz
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 206 participants
Where: No sites listed yet
Study dates: Jan 2005to Jul 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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

Read the detailed description

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.

Conditions: HIV Infections, Acquired Immunodeficiency Syndrome
Being tested: Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy, Comparator: efavirenz, Comparator: tenofovir, Comparator: lamivudine
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: MK0518 monotherapyDrug
MK0518 twice daily for 10 days
Comparator: MK0518 combination therapyDrug
MK0518 twice daily for 48 weeks
Comparator: efavirenzDrug
efavirenz 600 mg every night at bedtime for 48 weeks
Comparator: tenofovirDrug
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudineDrug
lamivudine 300 mg daily for 48 weeks
Placebo monotherapyDrug
Placebo to MK0518 twice daily

Study groups in NCT00100048
Study group	Role	What they receive
600 mg monotherapy	Experimental	MK0518 600 mg twice daily Receives: Drug: Comparator: MK0518 monotherapy
400 mg monotherapy	Experimental	MK0518 400 mg twice daily Receives: Drug: Comparator: MK0518 monotherapy
200 mg monotherapy	Experimental	MK0518 200 mg twice daily Receives: Drug: Comparator: MK0518 monotherapy
100 mg monotherapy	Experimental	MK0518 100 mg twice daily Receives: Drug: Comparator: MK0518 monotherapy
placebo monotherapy	Placebo comparator	Placebo to MK0518 twice daily Receives: Drug: Placebo monotherapy
600 mg combo therapy	Experimental	MK0518 600 mg + tenofovir + lamivudine Receives: Drug: Comparator: MK0518 combination therapy; Drug: Comparator: tenofovir; Drug: Comparator: lamivudine
400 mg combo therapy	Experimental	MK0518 400 mg + tenofovir + lamivudine Receives: Drug: Comparator: MK0518 combination therapy; Drug: Comparator: tenofovir; Drug: Comparator: lamivudine
200 mg combo therapy	Experimental	MK0518 200 mg + tenofovir + lamivudine Receives: Drug: Comparator: MK0518 combination therapy; Drug: Comparator: tenofovir; Drug: Comparator: lamivudine
100 mg combo therapy	Experimental	MK0518 100 mg + tenofovir + lamivudine Receives: Drug: Comparator: MK0518 combination therapy; Drug: Comparator: tenofovir; Drug: Comparator: lamivudine
EFV combo therapy	Active comparator	efavirenz + tenofovir + lamivudine Receives: Drug: Comparator: efavirenz; Drug: Comparator: tenofovir; Drug: Comparator: lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
Measured: Baseline and Day 10
Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
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.
Measured: 10 days
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
Measured: Week 24
Number of Patients With Clinical Adverse Experiences (CAEs)
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.
Measured: 48 weeks
Number of Patients With Serious CAEs (Cohort I and II Combined)
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
Measured: 48 weeks
Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
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
Measured: 144 Weeks
Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
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.
Measured: Week 240
Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
Measured: Week 240

Secondary outcomes (9)

Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
Measured: Week 24
Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)
Measured: Baseline and Week 24
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Measured: Baseline and Week 24
Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
Measured: 96 Weeks
Change From Baseline in Plasma HIV RNA at Week 96
Measured: Baseline and Week 96
Change From Baseline in CD4 Cell Count at Week 96
Measured: Baseline and Week 96
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Measured: Week 240
Change From Baseline in Plasma HIV RNA at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.
Measured: Baseline and Week 240
Change From Baseline in CD4 (T-helper) Cell Count at Week 240
Change in number of CD4 cells/mm^3 from baseline to Week 240.
Measured: Baseline and Week 240

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jul 2010

First posted23 Dec 2004 (estimated)
Study startJan 2005
Primary completionOct 2006
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00100048
Sponsor's protocol ID: 0518-004
Other IDs: 2004_096
Status last verified: Sep 2015
First submitted: 22 Dec 2004
Last updated: 9 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956.
PubMed 17133211
Murray JM, Emery S, Kelleher AD, Law M, Chen J, Hazuda DJ, Nguyen BY, Teppler H, Cooper DA. Antiretroviral therapy with the integrase inhibitor raltegravir alters decay kinetics of HIV, significantly reducing the second phase. AIDS. 2007 Nov 12;21(17):2315-21. doi: 10.1097/QAD.0b013e3282f12377.
PubMed 18090280
Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c.
PubMed 17721395
Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Campbell H, Strohmaier KM, Wan H, Danovich RM, Teppler H; Protocol 004 Part II Study Team. Sustained antiretroviral effect of raltegravir after 96 weeks of combination therapy in treatment-naive patients with HIV-1 infection. J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):350-6. doi: 10.1097/QAI.0b013e3181b064b0.
PubMed 19648823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00100048
Acronym / sponsor ID: 0518-004
Conditions: HIV Infections, Acquired Immunodeficiency Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Oct 2006 (actual)
Study completion: Jul 2010 (actual)
First posted: 23 Dec 2004 (estimated)
Results: Posted 29 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
600 mg monotherapy	Experimental	Drug: Comparator: MK0518 monotherapyMK0518 600 mg twice daily
400 mg monotherapy	Experimental	Drug: Comparator: MK0518 monotherapyMK0518 400 mg twice daily
200 mg monotherapy	Experimental	Drug: Comparator: MK0518 monotherapyMK0518 200 mg twice daily
100 mg monotherapy	Experimental	Drug: Comparator: MK0518 monotherapyMK0518 100 mg twice daily
placebo monotherapy	Placebo comparator	Drug: Placebo monotherapyPlacebo to MK0518 twice daily
600 mg combo therapy	Experimental	Drug: Comparator: MK0518 combination therapy, Drug: Comparator: tenofovir, Drug: Comparator: lamivudineMK0518 600 mg + tenofovir + lamivudine
400 mg combo therapy	Experimental	Drug: Comparator: MK0518 combination therapy, Drug: Comparator: tenofovir, Drug: Comparator: lamivudineMK0518 400 mg + tenofovir + lamivudine
200 mg combo therapy	Experimental	Drug: Comparator: MK0518 combination therapy, Drug: Comparator: tenofovir, Drug: Comparator: lamivudineMK0518 200 mg + tenofovir + lamivudine
100 mg combo therapy	Experimental	Drug: Comparator: MK0518 combination therapy, Drug: Comparator: tenofovir, Drug: Comparator: lamivudineMK0518 100 mg + tenofovir + lamivudine
EFV combo therapy	Active comparator	Drug: Comparator: efavirenz, Drug: Comparator: tenofovir, Drug: Comparator: lamivudineefavirenz + tenofovir + lamivudine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient must be HIV positive who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)
First extension: Patient completed the 48-week base study
Second extension: Patient completed the first 144-week extension study

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparator: MK0518 monotherapyMK0518 twice daily for 10 days	Drug	100 mg monotherapy, 200 mg monotherapy, 400 mg monotherapy, 600 mg monotherapy
Comparator: MK0518 combination therapyMK0518 twice daily for 48 weeks	Drug	100 mg combo therapy, 200 mg combo therapy, 400 mg combo therapy, 600 mg combo therapy
Comparator: efavirenzefavirenz 600 mg every night at bedtime for 48 weeks	Drug	EFV combo therapy
Comparator: tenofovirtenofovir 300 mg daily for 48 weeks	Drug	100 mg combo therapy, 200 mg combo therapy, 400 mg combo therapy, 600 mg combo therapy, EFV combo therapy
Comparator: lamivudinelamivudine 300 mg daily for 48 weeks	Drug	100 mg combo therapy, 200 mg combo therapy, 400 mg combo therapy, 600 mg combo therapy, EFV combo therapy
Placebo monotherapyPlacebo to MK0518 twice daily	Drug	placebo monotherapy

Primary outcome

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.

9 secondary outcomes

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
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
Time frame: Baseline and Week 24
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
Change From Baseline in Plasma HIV RNA at Week 240
Time frame: Baseline and Week 240
Change From Baseline in CD4 (T-helper) Cell Count at Week 240
Time frame: Baseline and Week 240

Results and safety

Results posted to the registry on 29 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0518 100 mg b.i.d.	7	7
MK0518 200 mg b.i.d	7	7
MK0518 400 mg b.i.d.	6	6
MK0518 600 mg b.i.d.	8	8
Placebo	7	7
Efavirenz 600 mg q.h.s.	0	0

Primary outcome: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)

Time frame: Baseline and Day 10. Mean (95% Confidence Interval). Unit: copies/mL

Measure	MK0518 100 mg b.i.d. n = 7	MK0518 200 mg b.i.d n = 7	MK0518 400 mg b.i.d. n = 6	MK0518 600 mg b.i.d. n = 8	Placebo n = 7
Value	-1.93 (-2.44 to -1.42)	-1.98 (-2.49 to -1.47)	-1.66 (-1.99 to -1.34)	-2.16 (-2.55 to -1.77)	-0.17 (-0.42 to 0.07)

Population analysed: The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.

Primary outcome: Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)

Time frame: 10 days. Number. Unit: participants

Measure	MK0518 100 mg b.i.d. n = 7	MK0518 200 mg b.i.d. n = 7	MK0518 400 mg b.i.d. n = 6	MK0518 600 mg b.i.d. n = 8	Placebo n = 7
With CAEs	4	2	3	5	5
Without CAEs	3	5	3	3	2
With Serious CAEs	0	0	0	0	0
Without Serious CAEs	7	7	6	8	7

Population analysed: The analysis population is based upon the All Patients As Treated (APaT) approach.

Primary outcome: Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)

Time frame: Week 24. Number. Unit: participants

Measure	MK0518 100 mg b.i.d. n = 33	MK0518 200 mg b.i.d n = 33	MK0518 400 mg b.i.d. n = 35	MK0518 600 mg b.i.d. n = 34	EFV Combo Therapy n = 34
Value	31	27	35	32	32

Primary outcome: Number of Patients With Clinical Adverse Experiences (CAEs)

Time frame: 48 weeks. Number. Unit: participants

Measure	MK0518 100 mg b.i.d. n = 39	MK0518 200 mg b.i.d. n = 40	MK0518 400 mg b.i.d. n = 41	MK0518 600 mg b.i.d. n = 40	EFV Combo Therapy n = 38
With CAEs	31	35	36	35	34
Without CAEs	8	5	5	5	4

Population analysed: The analysis population is based upon the All Patients As Treated (APaT) approach.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0518 b.i.d.	25 of 160 (15.6%)	147 of 160 (91.9%)	Not reported
Efavirenz	4 of 38 (10.5%)	35 of 38 (92.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17133211Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956.
Background: PubMed 18090280Murray JM, Emery S, Kelleher AD, Law M, Chen J, Hazuda DJ, Nguyen BY, Teppler H, Cooper DA. Antiretroviral therapy with the integrase inhibitor raltegravir alters decay kinetics of HIV, significantly reducing the second phase. AIDS. 2007 Nov 12;21(17):2315-21. doi: 10.1097/QAD.0b013e3282f12377.
Background: PubMed 17721395Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c.
Background: PubMed 19648823Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Campbell H, Strohmaier KM, Wan H, Danovich RM, Teppler H; Protocol 004 Part II Study Team. Sustained antiretroviral effect of raltegravir after 96 weeks of combination therapy in treatment-naive patients with HIV-1 infection. J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):350-6. doi: 10.1097/QAI.0b013e3181b064b0.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) (time frame: Baseline and Day 10). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00100048, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.