HIV InfectionsPhase 2NCT00215852
A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects
A Phase 2 study testing Alferon LDO in people with HIV Infections, run by AIM ImmunoTech Inc. at 2 sites in United States.
Trial summary
To conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. 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?
- Alferon LDO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Apr 2009
- 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
- 18 years of age or older.
- HIV-1 plasma RNA > 500 copies/ml (Roche Amplicor assay) or similar assay within 45 days of starting oral dosing.
- Karnofsky performance status of 100
- Subjects must be asymptomatic with regard to HIV related clinical symptoms including the following opportunistic infections: Oral candidiasis (thrush), cutaneous herpes simplex, fever, diarrhea, weight loss ≥ 10% of body weight, seborrheic dermatitis, chronic mucocutaneous fungal infections or Kaposi's sarcoma. Subjects with a history of AIDS are not eligible.
- Serum creatinine ≤ 1.5 ULN; serum bilirubin ≤ 2.0 ULN.
- Total WBC ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3.
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- Absolute CD4 cell count greater than 400 (based on the average CD4 count from the two pretherapy tests).
- Hemoglobin > 10.0 g/dl.
- AST < 4 times upper normal limit.
- ALT < 4 times upper normal limit.
- Serum Albumin > 2.0 g/dl.
- Written informed consent.
- Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test within 14 days of entry.
- For those subjects who are on antiretroviral therapy, they must have been on a stable dose schedule for at least 90 days prior to study entry and must continue on the same schedule during the treatment phase of this study.
Who cannot join
- Pregnant or nursing women, or women not using an effective form of contraception.
- Less than 18 years of age.
- Active IV drug users.
- Absolute CD4 ≤ 400 mm3 (based on the average CD4 counts from the two pretherapy tests).
- Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.
- Receipt of any immunomodulator such as BCG vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.
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- Evidence of chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period.
- Unlikely or unable to comply with the requirements of the protocol.
- Patients unwilling or unable to give informed consent.
- Patients on any other concurrent experimental medication.
- Concurrent, chronic prophylactic use of any systemic antifungal medication (e.g. ketoconazole, fluconazole, clotrimazole) or of any systemic anti-viral (e.g. acyclovir or ganciclovir) except for antiretroviral therapy.
- Patients using any form of interferon therapy during the 6 weeks prior to study entry. If prior interferon therapy has been received, the subject must not have known development of antibodies to interferon.
- Hospitalized subjects, or those with an active viral infection other than HIV, within 2 weeks of study entry.
- Transfusion dependent subjects (subjects requiring > 1 unit of packed RBC per month within the 3 months prior to study entry).
- Subjects who are symptomatic of their HIV infection at study entry.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Drexel University School of Medicine
Philadelphia, Pennsylvania, 19102
Philadelphia FIGHTS
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized, Dose-Ranging Study of Alferon® LDO [Low Dose Interferon Alfa-n3 (Human Leukocyte Derived)] in Asymptomatic HIV+ Subjects
To conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels.
Read the detailed description
This study will be an open-label, randomized outpatient study in HIV infected subjects using a range of doses of Alferon LDO. The first nine (9) patients enrolled will not be randomized. Instead, the first three (3) patients will receive 500 IU, the second three (3) patients will receive 1000 IU, and the final three (3) patients will receive 2000 IU. Once three (3) patients at a given dose level have received at least 8 doses without grade 3 toxicity, patients may be enrolled at the next higher dose level. Following enrollment of the first nine (9) patients, additional patients will be randomized to receive one of the three (3) dose levels of Alferon® LDO. The Alferon LDO (natural interferon alfa-n3) will be in a buffer solution and taken orally once each day for 10 consecutive days at doses equal to 500 IU, 1000 IU, or 2000 IU.
Pretherapy baseline evaluations will be performed within the three (3) week period prior to randomization.
Drug will be dispensed for a ten day treatment period, during which time any clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1, 4, and 10 on study days 2, 5, and 11, respectively.
- Conditions
- HIV Infections
- Being tested
- Alferon LDO
- Keywords
- Alferon LDO, Low Dose Oral Interferon, Alfa-n3, Human Leukocyte Derived, HIV, Asymptomatic 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.
Alferon LDODrug
500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 500 IU Receives: Drug: Alferon LDO |
| 2 | Active comparator | 1000 IU Receives: Drug: Alferon LDO |
| 3 | Active comparator | 2000 IU Receives: Drug: Alferon LDO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression analysis
Measured: Days 0, 2, 5, 11, 12 and 16
Secondary outcomes (1)
CD4 Level
Measured: Days 0, 11 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionApr 2009
- Study completionApr 2009
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIM ImmunoTech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Strayer, MD, Study director, AIM ImmunoTech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215852
- Sponsor's protocol ID
- LDO-101
- Status last verified
- Aug 2013
- First submitted
- 16 Sep 2005
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Dose-Ranging Study of Alferon® LDO [Low Dose Interferon Alfa-n3 (Human Leukocyte Derived)] in Asymptomatic HIV+ Subjects
- ClinicalTrials.gov ID
- NCT00215852
- Acronym / sponsor ID
- LDO-101
- Conditions
- HIV Infections
- Keywords
- Alferon LDO, Low Dose Oral Interferon, Alfa-n3, Human Leukocyte Derived, HIV, Asymptomatic HIV, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AIM ImmunoTech Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Sep 2005 (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 conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels.
Detailed description
This study will be an open-label, randomized outpatient study in HIV infected subjects using a range of doses of Alferon LDO. The first nine (9) patients enrolled will not be randomized. Instead, the first three (3) patients will receive 500 IU, the second three (3) patients will receive 1000 IU, and the final three (3) patients will receive 2000 IU. Once three (3) patients at a given dose level have received at least 8 doses without grade 3 toxicity, patients may be enrolled at the next higher dose level. Following enrollment of the first nine (9) patients, additional patients will be randomized to receive one of the three (3) dose levels of Alferon® LDO. The Alferon LDO (natural interferon alfa-n3) will be in a buffer solution and taken orally once each day for 10 consecutive days at doses equal to 500 IU, 1000 IU, or 2000 IU.
Pretherapy baseline evaluations will be performed within the three (3) week period prior to randomization.
Drug will be dispensed for a ten day treatment period, during which time any clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1, 4, and 10 on study days 2, 5, and 11, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Alferon LDO500 IU |
| 2 | Active comparator | Drug: Alferon LDO1000 IU |
| 3 | Active comparator | Drug: Alferon LDO2000 IU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years of age or older.
- HIV-1 plasma RNA > 500 copies/ml (Roche Amplicor assay) or similar assay within 45 days of starting oral dosing.
- Karnofsky performance status of 100
- Subjects must be asymptomatic with regard to HIV related clinical symptoms including the following opportunistic infections: Oral candidiasis (thrush), cutaneous herpes simplex, fever, diarrhea, weight loss ≥ 10% of body weight, seborrheic dermatitis, chronic mucocutaneous fungal infections or Kaposi's sarcoma. Subjects with a history of AIDS are not eligible.
- Serum creatinine ≤ 1.5 ULN; serum bilirubin ≤ 2.0 ULN.
Key exclusion criteria (15 listed)
- Pregnant or nursing women, or women not using an effective form of contraception.
- Less than 18 years of age.
- Active IV drug users.
- Absolute CD4 ≤ 400 mm3 (based on the average CD4 counts from the two pretherapy tests).
- Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.
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 |
|---|---|---|
| Alferon LDO500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle. | Drug | 1, 2, 3 |
Primary outcome
Gene expression analysis
Time frame: Days 0, 2, 5, 11, 12 and 16
1 secondary outcome
CD4 Level
Time frame: Days 0, 11 and 16
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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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.
David R Strayer, MD study director
AIM ImmunoTech Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alferon LDO in people with HIV Infections, run by AIM ImmunoTech Inc. at 2 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 14 inclusion and 15 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: stopped early, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 was stopped early. Results are not available in the source record.
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?
Gene expression analysis (time frame: Days 0, 2, 5, 11, 12 and 16). 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 4 Sep 2013.