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

A Phase 3 study testing raltegravir potassium in people with HIV Infections, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV Infections
What is being tested?: raltegravir potassium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 351 participants
Where: No sites listed yet
Study dates: Feb 2006to May 2011
Phase: Phase 3
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Patient less than 16 years old
Additional study criteria will be discussed and identified by the study doctor

About this study

Official 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

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.

Read the detailed description

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.

Conditions: HIV Infections
Being tested: raltegravir potassium, Comparator: placebo
Keywords: Treatment Experienced
Medical subject headings: HIV Infections

What participants receive

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

raltegravir potassiumDrug
Also called ISENTRESS™
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Comparator: placeboDrug
Placebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.

Study groups in NCT00293254
Study group	Role	What they receive
1	Experimental	raltegravir potassium Receives: Drug: raltegravir potassium
2	Placebo comparator	Placebo Receives: Drug: Comparator: placebo

What is being measured

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

Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
Measured: 16 Weeks
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
Measured: 48 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
Measured: 156 Weeks
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
Measured: 240 Weeks

Secondary outcomes (13)

Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
Measured: 16 Weeks
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
Measured: 48 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
Measured: 156 Weeks
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
Measured: 240 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
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).
Measured: 156 Weeks
Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)
Measured: Baseline and Week 16
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Measured: Baseline and Week 48
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
Measured: Baseline and Week 156
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
Measured: Baseline and Week 240
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)
Measured: Baseline and Week 16
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)
Measured: Baseline and Week 48
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)
Measured: Baseline and Week 156
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
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.

Feb 2006May 2011

First posted17 Feb 2006 (estimated)
Study startFeb 2006
Primary completionOct 2007
Study completionMay 2011

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 (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00293254
Sponsor's protocol ID: 0518-019
Other IDs: 2005_097
Status last verified: Feb 2017
First submitted: 15 Feb 2006
Last updated: 21 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975.
PubMed 18650512
Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978.
PubMed 18650513
Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
PubMed 20085491

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 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00293254
Acronym / sponsor ID: 0518-019
Conditions: HIV Infections
Keywords: Treatment Experienced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Oct 2007 (actual)
Study completion: May 2011 (actual)
First posted: 17 Feb 2006 (estimated)
Results: Posted 30 Sep 2009

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: raltegravir potassiumraltegravir potassium
2	Placebo comparator	Drug: Comparator: placeboPlacebo

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Patient less than 16 years old
Additional study criteria will be discussed and identified by the study doctor

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
raltegravir potassiumAlso: ISENTRESS™Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.	Drug	1
Comparator: placeboPlacebo p.o. b.i.d. with optimized background therapy. Treatment period of 48 weeks.	Drug	2

Primary outcome

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
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
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
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

13 secondary outcomes

Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Time frame: 16 Weeks
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Time frame: 48 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Time frame: 156 Weeks
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Time frame: 240 Weeks
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
Time frame: 156 Weeks
Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Time frame: Baseline and Week 48
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Time frame: Baseline and Week 156
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Time frame: Baseline and Week 240
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Time frame: Baseline and Week 48
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
Time frame: Baseline and Week 156
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Time frame: Baseline and Week 240

Results and safety

Results posted to the registry on 30 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Raltegravir 400 mg b.i.d. + OBT	232	177
Placebo + OBT	119	55

Primary outcome: Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16

Time frame: 16 Weeks. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Raltegravir 400 mg b.i.d. + OBT n = 229	Placebo + OBT n = 119
Value	77.3 (71.3 to 82.6)	42.9 (33.8 to 52.3)

Primary outcome: Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48

Time frame: 48 Weeks. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Raltegravir 400 mg b.i.d. + OBT n = 228	Placebo + OBT n = 119
Value	71.1 (64.7 to 76.8)	37.8 (29.1 to 47.2)

Primary outcome: Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL

Time frame: 156 Weeks. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Raltegravir 400 mg b.i.d. + OBT n = 229	Placebo + OBT n = 119
Value	50.2 (43.6 to 56.9)	21.0 (14.1 to 29.4)

Population analysed: The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures. Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.

Primary outcome: Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL

Time frame: 240 Weeks. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Raltegravir 400 mg b.i.d. + OBT n = 230	Placebo + OBT n = 119
Value	45.7 (39.1 to 52.3)	13.4 (7.9 to 20.9)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 240 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir 400 mg b.i.d. Plus OBT	80 of 230 (34.8%)	214 of 230 (93%)	Not reported
Placebo Plus OBT	54 of 119 (45.4%)	111 of 119 (93.3%)	Not reported

Limitations and caveats (from the sponsor): Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18650512Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975.
Background: PubMed 18650513Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978.
Results publication: PubMed 20085491Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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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?

A Phase 3 study testing raltegravir potassium in people with HIV Infections, run by Merck Sharp & Dohme LLC.

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 3 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 21 Mar 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Sep 2009). 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?

Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16 (time frame: 16 Weeks). The study lists 4 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 NCT00293254, which also lists 3 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 21 Mar 2017.