HIV InfectionsNCT00000844
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3
A study testing Interferon alfa-n3 and Interferon alfa-n1 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
Trial summary
To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Interferon alfa-n3 and Interferon alfa-n1
- How many people
- 560 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento Jun 2002
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Symptomatic HIV infection.
- CD4 count 50 - 350 cells/mm3.
- Prior Medication:
- Allowed:
- Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).
- Maintenance therapy for a chronic condition.
Who cannot join
- Patients with the following prior condition are excluded:
- Change in antiretroviral therapy within past 6 weeks.
- Prior Medication:
- Excluded:
- Oral IFN-alpha or other immune-based therapy within the past month.
- Therapy for any acute disease within the past week.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Henry Ford Hosp
Detroit, Michigan, 48202
King - Drew Med Ctr
Los Angeles, California, 90059
Univ of Minnesota Hosp
Minneapolis, Minnesota, 55455
Meharry Med College
Nashville, Tennessee, 37208
Yale Univ / New Haven
New Haven, Connecticut, 065102483
Dr Barbara Justice
New York, New York, 10031
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104
AIDS Community Research Consortium
Redwood City, California, 94063
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Abundant Life Clinic Foundation
Washington D.C., District of Columbia, 20019
Howard Univ Hosp
Washington D.C., District of Columbia, 20059
Med Ctr of Delaware / Wilmington Hosp
Wilmington, Delaware, 19801
About this study
To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
Read the detailed description
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.
- Conditions
- HIV Infections
- Being tested
- Interferon alfa-n3, Interferon alfa-n1
- Keywords
- Drug Therapy, Combination, Adjuvants, Immunologic, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon-alpha
- 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 alfa-n3Drug
Interferon alfa-n1Drug
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 completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 National Institute of Allergy and Infectious Diseases (NIAID)The 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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 560 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alston B, Study chairStandiford H, Study chairKumi J, Study chairGreaves W, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000844
- Sponsor's protocol ID
- DATRI 022
- Other IDs
- 11727
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.
PubMed 11363808Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.
PubMed 11364607Alston B, Ellenberg JH, Standiford HC, Muth K, Martinez A, Greaves W, Kumi J. A multicenter, randomized, controlled trial of three preparations of low-dose oral alpha-interferon in HIV-infected patients with CD4+ counts between 50 and 350 cells/mm(3). Division of AIDS Treatment Research Initiative (DATRI) 022 Study Group. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):348-57. doi: 10.1097/00126334-199912010-00005.
PubMed 10634196
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3
- ClinicalTrials.gov ID
- NCT00000844
- Acronym / sponsor ID
- DATRI 022
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Adjuvants, Immunologic, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon-alpha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 2002 (actual)
- 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 effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
Detailed description
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Symptomatic HIV infection.
- CD4 count 50 - 350 cells/mm3.
- Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).
- Maintenance therapy for a chronic condition.
Key exclusion criteria (6 listed)
- Change in antiretroviral therapy within past 6 weeks.
- Oral IFN-alpha or other immune-based therapy within the past month.
- Therapy for any acute disease within the past week.
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 alfa-n3 | Drug | – |
| Interferon alfa-n1 | 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 3 Nov 2021.
- Background: PubMed 11363808Randall P. Low-dose oral alpha interferon study opens. NIAID AIDS Agenda. 1996 Jun:4-5.
- Background: PubMed 11364607Low-dose oral alpha interferon trial closes. NIAID AIDS Agenda. 1997 Aug:10.
- Results publication: PubMed 10634196Alston B, Ellenberg JH, Standiford HC, Muth K, Martinez A, Greaves W, Kumi J. A multicenter, randomized, controlled trial of three preparations of low-dose oral alpha-interferon in HIV-infected patients with CD4+ counts between 50 and 350 cells/mm(3). Division of AIDS Treatment Research Initiative (DATRI) 022 Study Group. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):348-57. doi: 10.1097/00126334-199912010-00005.
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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.
Alston B study chair
Standiford H study chair
Kumi J study chair
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon alfa-n3 and Interferon alfa-n1 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 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 7 inclusion and 6 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
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?
On the ClinicalTrials.gov record for NCT00000844, 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 3 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.