HIV SeropositivityPhase 2NCT00035893
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
A Phase 2 study testing poly I-poly C12U in people with HIV Seropositivity and HIV Infection, run by AIM ImmunoTech Inc. at 10 sites in United States.
Trial summary
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Seropositivity, HIV Infection
- What is being tested?
- poly I-poly C12U
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2001to Aug 2006
- 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
- Adults at least 18 years of age.
- CD4 cell count of > 400 cells.
- Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.
- History of virologic success with suppression of HIV RNA level < 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a HAART regiment. During the four months prior to starting Baseline, continuing through Baseline and the 64 week study period, the HAART regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs:
- Abacavir (Ziagen)
- Zidovudine (Retrovir) AZT
- Zalcitabine (Hivid) ddC
- Didanosine (Videx) ddl
- Stavudine (Zerit) d4T
- Efavirenz (Sustiva)
- Indinavir (Crixivan)
- Ritonavir (Norvir)
- Nelfinavir (Viracept)
- Amprenavir (Agenerase) Only one HIV plasma RNA level > 50, but < 100 copies/ml is permitted during the four month period immediately prior to starting Baseline.
- Karnofsky performance status of at least 70.
- The following laboratory parameters within 21 days prior to treatment:
- Hemoglobin > 9.2 g/dL for men and > 8.9 g/dL for women;
- Neutrophil count > 1000;
- Platelet count > 75,000;
- AST/ALT < 4.0 x upper limit of normal (ULN);
- Serum creatinine < 1.5 x ULN or a creatinine clearance > 50 mL/min.
- Ability and willingness to give written informed consent.
- For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Females of child bearing potential agree to use an effective means of contraception.
- The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Julia Torres, MD
Fort Lauderdale, Florida, 33306
Orange County Center for Special Immunology
Fountain Valley, California, 92708
AltaMed Health Services Corporation
Los Angeles, California, 90022
Allied Clinical Trials
Miami, Florida, 33156
St. Michael's Medical Center
Newark, New Jersey, 07102
Circle Medical Center
Norwalk, Connecticut, 06851
W. Chris Woodward, DO
Reading, Pennsylvania, 19601
Christopher Lucasti, D.O.
Somers Point, New Jersey, 08244
Scott Ubillos, MD
Tampa, Florida, 33607
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
About this study
Official title: The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.
- Conditions
- HIV Seropositivity, HIV Infection
- Being tested
- poly I-poly C12U
- Keywords
- treatment interruption, HIV Infections
- Medical subject headings
- HIV Seropositivity, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poly I-poly C12UDrug
Also called Ampligen, Rintatolimod
200-400 mg IV infusions 2x/week for 64 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ampligen | Experimental | Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks. Receives: Drug: poly I-poly C12U |
| No Ampligen | No intervention | No Ampligen administered for first 64 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAART-free time interval
To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
Measured: HAART adherence questionnaire completed weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2002 (estimated)
- Study startMay 2001
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies 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
- 40 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
- NCT00035893
- Sponsor's protocol ID
- AMP 720
- Status last verified
- Apr 2013
- First submitted
- 6 May 2002
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.
- ClinicalTrials.gov ID
- NCT00035893
- Acronym / sponsor ID
- AMP 720
- Conditions
- HIV Seropositivity, HIV Infection
- Keywords
- treatment interruption, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AIM ImmunoTech Inc.Industry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 7 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 an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ampligen | Experimental | Drug: poly I-poly C12UAmpligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks. |
| No Ampligen | No intervention | –No Ampligen administered for first 64 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| poly I-poly C12UAlso: Ampligen, Rintatolimod200-400 mg IV infusions 2x/week for 64 weeks | Drug | Ampligen |
Primary outcome
HAART-free time interval
Time frame: HAART adherence questionnaire completed weekly
To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
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 17 Apr 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.
10 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 poly I-poly C12U in people with HIV Seropositivity and HIV Infection, run by AIM ImmunoTech Inc. at 10 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?
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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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.
What does the primary outcome measure?
HAART-free time interval (time frame: HAART adherence questionnaire completed weekly). 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 17 Apr 2013.