HIV InfectionsPhase 2NCT00541463
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
A Phase 2 study testing MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks and Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks in people with HIV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks and Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to May 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- At least 18 years of age
- HIV positive
- No active heart disease
Who cannot join
- Pregnant or breast feeding
- Unwilling to use birth control or abstinence to prevent pregnancy
- Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
- Plan to receive NNRTIs while in the study
- Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
- Alcohol or substance abuse
- Hepatitis
About this study
Official title: A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen
A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.
- Conditions
- HIV Infections
- Being tested
- MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks, Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks
- Keywords
- HIV, 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.
MK0639, indinavir sulfate / Duration of Treatment: 48 WeeksDrug
Comparator: nelfinavir mesylate / Duration of Treatment: 48 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Secondary outcomes (1)
CD4 cell counts will be measured at predetermined time points to determine change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startJan 2001
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541463
- Sponsor's protocol ID
- 0639-112
- Other IDs
- 2007_642
- Status last verified
- Feb 2017
- First submitted
- 9 Oct 2007
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen
- ClinicalTrials.gov ID
- NCT00541463
- Acronym / sponsor ID
- 0639-112
- Conditions
- HIV Infections
- Keywords
- HIV, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- May 2003 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- HIV positive
- No active heart disease
Key exclusion criteria (7 listed)
- Pregnant or breast feeding
- Unwilling to use birth control or abstinence to prevent pregnancy
- Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
- Plan to receive NNRTIs while in the study
- Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
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 |
|---|---|---|
| MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks | Drug | – |
| Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks | Drug | – |
Primary outcome
Plasma viral RNA levels will be measured at predetermined time points to determine mean change
1 secondary outcome
CD4 cell counts will be measured at predetermined time points to determine change from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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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 2 study testing MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks and Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks 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 7 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 17 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma viral RNA levels will be measured at predetermined time points to determine mean change. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017.