HIV InfectionsPhase 2NCT00005012
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
A Phase 2 study testing Peginterferon alfa-2b in people with HIV Infections, run by Schering-Plough at 22 sites in 2 countries.
Trial summary
The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Peginterferon alfa-2b
- How many people
- 250 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Mar 2000to Sep 2000
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Have HIV levels of more than 2000 copies/ml.
- Have failed their current HAART (had a significant increase in their HIV levels with HAART).
- Have a CD4 cell count greater than 200 cells/microL.
- Have had more than 6 months of HAART.
- Have been on their current HAART for at least 6 weeks.
- Agree to use an effective method of birth control during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a history of a serious mental disorder.
- Are allergic to interferons.
- Are pregnant or breast-feeding.
- Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Piedmont Physicians at Vinings
Atlanta, Georgia, 30339
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, 212011192
East Bay AIDS Ctr
Berkeley, California, 94705
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, 02111
Southwestern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
TRIAD Health Practice
Chicago, Illinois, 60657
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
Amelia Ct Clinic
Dallas, Texas, 75235
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
Joseph C Gathe
Houston, Texas, 77004
Duval County Health Department
Jacksonville, Florida, 32206
Univ of Miami School of Medicine
Miami, Florida, 33136
Beth Israel Med Ctr
New York, New York, 10003
MCP Hahnemann Univ
Philadelphia, Pennsylvania, 19102
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Regions Hosp
Saint Paul, Minnesota, 55101
Infectious Diseases Associates
Sarasota, Florida, 34239
Washington Univ
St Louis, Missouri, 63110
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
About this study
Official title: Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
Read the detailed description
At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.
- Conditions
- HIV Infections
- Being tested
- Peginterferon alfa-2b
- Keywords
- Interferon Alfa-2b, Lymphocyte Transformation, CD4 Lymphocyte Count, RNA, Viral, Virus Inhibitors, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2bDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startMar 2000
- Study completionSep 2000
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.
- 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
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005012
- Sponsor's protocol ID
- B010
- Other IDs
- P00737
- Status last verified
- Aug 2000
- First submitted
- 29 Mar 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
- ClinicalTrials.gov ID
- NCT00005012
- Acronym / sponsor ID
- B010
- Conditions
- HIV Infections
- Keywords
- Interferon Alfa-2b, Lymphocyte Transformation, CD4 Lymphocyte Count, RNA, Viral, Virus Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Study completion
- Sep 2000
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
Detailed description
At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have HIV levels of more than 2000 copies/ml.
- Have failed their current HAART (had a significant increase in their HIV levels with HAART).
- Have a CD4 cell count greater than 200 cells/microL.
- Have had more than 6 months of HAART.
- Have been on their current HAART for at least 6 weeks.
Key exclusion criteria (5 listed)
- Have a history of a serious mental disorder.
- Are allergic to interferons.
- Are pregnant or breast-feeding.
- Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
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 |
|---|---|---|
| Peginterferon alfa-2b | 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 24 Jun 2005.
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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.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon alfa-2b in people with HIV Infections, run by Schering-Plough at 22 sites in 2 countries.
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 7 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 24 Jun 2005.