HIV InfectionsPhase 3NCT00002238
Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
A Phase 3 study testing Interferon beta-1b and Zidovudine in people with HIV Infections, run by Bayer at 25 sites in United States.
Trial summary
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen. 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?
- Interferon beta-1b and Zidovudine
- How many people
- Not given
- Where
- 25 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Patient must have:
- Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry.
- Acceptable hepatic and renal function.
- AMENDED to delete the following sentence:
- Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day).
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Concurrent, ineffectively controlled opportunistic infections.
- Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy.
- Proteinuria of 2+ or greater.
- HIV encephalopathy.
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- HIV wasting syndrome.
- New York Heart Classification III or IV.
- Uncontrolled angina pectoris.
- Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias.
- Concurrent Medication:
- Excluded:
- Antiretrovirals other than zidovudine (AZT) or Betaseron.
- Chronic acyclovir therapy.
- Acetaminophen.
- Patients with the following are excluded:
- Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to:
- Intolerance at a dose of 500 to 600 mg/day.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study.
- Prior Medication:
- Excluded within 30 days of study entry:
- Cytotoxic chemotherapy.
- Prior therapy with alpha, beta, or gamma interferons.
- Active drug or alcohol abuse.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Alta Bates / Herrick Hosp
Berkeley, California, 94704
Boston Med Ctr
Boston, Massachusetts, 02118
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Univ TX Galveston Med Branch
Galveston, Texas, 77550
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
Cedars Sinai Med Ctr
Los Angeles, California, 90048
UCLA CARE Ctr
Los Angeles, California, 90095
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003
Chelsea Village Med Ctr
New York, New York, 10014
Dr Douglas Dieterich
New York, New York, 10016
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
UCI Med Ctr
Orange, California, 92668
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
Graduate Hosp
Philadelphia, Pennsylvania, 19146
Davies Med Ctr
San Francisco, California, 94114
Santa Clara Valley Med Ctr
San Jose, California, 95128
Univ of South Florida
Tampa, Florida, 33612
Dr William Davis
Washington D.C., District of Columbia, 20016
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.
- Conditions
- HIV Infections
- Being tested
- Interferon beta-1b, Zidovudine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Interferon Type I
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1bDrug
ZidovudineDrug
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)
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 BayerThe 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002238
- Sponsor's protocol ID
- 002A
- Other IDs
- TBO1-310188
- Status last verified
- Apr 1991
- First submitted
- 2 Nov 1999
- 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
- Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
- ClinicalTrials.gov ID
- NCT00002238
- Acronym / sponsor ID
- 002A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Interferon Type I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- 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.
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.
Study design
- Primary purpose
- Treatment
- 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 (8 listed)
- Zidovudine (AZT).
- Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry.
- Acceptable hepatic and renal function.
- AMENDED to delete the following sentence:
- Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day).
Key exclusion criteria (24 listed)
- Concurrent, ineffectively controlled opportunistic infections.
- Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy.
- Proteinuria of 2+ or greater.
- HIV encephalopathy.
- HIV wasting syndrome.
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 |
|---|---|---|
| Interferon beta-1b | Drug | – |
| Zidovudine | 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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon beta-1b and Zidovudine in people with HIV Infections, run by Bayer at 25 sites in United States.
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 8 inclusion and 24 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 25 sites in United States. 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 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 24 Jun 2005.