HIV InfectionsPhase 3NCT00035360
Phase III PEG-Intron in HIV-infected Patients (Study P00738)
A Phase 3 study testing PEG-Intron in people with HIV Infections and AIDS, run by Merck Sharp & Dohme LLC.
Trial summary
This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, AIDS
- What is being tested?
- PEG-Intron
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Oct 2003
- Phase
- Phase 3
- 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
- HIV positive
- History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI
- HIV RNA >400-<50,000 copies/mL
- Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN.
Who cannot join
- Current ribavirin therapy
- Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention
- Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures
- Concomitant use of immunosuppressants or cytotoxic agents
- History of seizure disorder requiring use of anticonvulsants
About this study
Official title: Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients
This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.
Read the detailed description
This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients.
Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months.
A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.
- Conditions
- HIV Infections, AIDS
- Being tested
- PEG-Intron
- Keywords
- PEG-Intron, treatment experienced
- 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.
PEG-IntronDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startMar 2002
- Primary completionOct 2003
- Study completionOct 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035360
- Sponsor's protocol ID
- P00738
- Status last verified
- Mar 2017
- First submitted
- 2 May 2002
- Last updated
- 10 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients
- ClinicalTrials.gov ID
- NCT00035360
- Acronym / sponsor ID
- P00738
- Conditions
- HIV Infections, AIDS
- Keywords
- PEG-Intron, treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 6 May 2002 (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.
This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.
Detailed description
This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients.
Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months.
A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive
- History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI
- HIV RNA >400-<50,000 copies/mL
- Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN.
Key exclusion criteria (5 listed)
- Current ribavirin therapy
- Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention
- Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures
- Concomitant use of immunosuppressants or cytotoxic agents
- History of seizure disorder requiring use of anticonvulsants
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 |
|---|---|---|
| PEG-Intron | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-Intron in people with HIV Infections and AIDS, 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 4 inclusion and 5 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 10 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. 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?
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.
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 10 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.