HIV SeropositivityPhase 2NCT00035581
Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
A Phase 2 study testing poly I-poly C12U in people with HIV Seropositivity and HIV Infection, run by AIM ImmunoTech Inc. at 7 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 "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR). 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
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2001to Sep 2005
- 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 >300 cells.
- HIV-1 plasma RNA >500 and <30,000 copies/ml. A qualifying ("screening") HIV-1 RNA level >500 and <30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:
- Abacavir (Ziagen)
- Zidovudine (Retrovir) AZT
- Zalcitabine (Hivid) ddC
- Didanosine (Videx) ddI
- Stavudine (Zerit) d4T
- Efavirenz (Sustiva)
- Indinavir (Crixivan)
- Ritonavir (Norvir)
- Nelfinavir (Viracept)
- Amprenavir (Agenerase) The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.
- History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI).
- Karnofsky performance status of at least 70.
- The following laboratory parameters within 14 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.
- For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Julia Torres, MD
Fort Lauderdale, Florida, 33306
Orange County Center for Special Immunology
Fountain Valley, California, 92708
St. Michael's Medical Center
Newark, New Jersey, 07102
Circle Medical Center
Norwalk, Connecticut, 06851
W. Chris Woodward, DO
Reading, Pennsylvania, 19601
Scott Ubillos, MD
Tampa, Florida, 33607
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
About this study
Official title: A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
- Conditions
- HIV Seropositivity, HIV Infection
- Being tested
- poly I-poly C12U
- Keywords
- treatment experienced, HIV Infections, HIV, HAART, early virologic failure
- 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 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ampligen | Experimental | Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks Receives: Drug: poly I-poly C12U |
| No Ampligen | No intervention | No Ampligen administered for first 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HIV-1 Viral Load
Evaluate the effects of adding Ampligen (or no Ampligen) to "HAART" in HIV+ patients for evidence of reductions in HIV-1 viral load in plasma using Roche Amplicor assay.
Measured: 4, 8, 12, 16, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startMay 2001
- Primary completionSep 2005
- Study completionSep 2005
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
- 16 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
- NCT00035581
- Sponsor's protocol ID
- AMP 719
- Status last verified
- Apr 2013
- First submitted
- 3 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
- A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease
- ClinicalTrials.gov ID
- NCT00035581
- Acronym / sponsor ID
- AMP 719
- Conditions
- HIV Seropositivity, HIV Infection
- Keywords
- treatment experienced, HIV Infections, HIV, HAART, early virologic failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AIM ImmunoTech Inc.Industry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 6 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 "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
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 (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks |
| No Ampligen | No intervention | –No Ampligen administered for first 24 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 24 weeks | Drug | Ampligen |
Primary outcome
Reduction in HIV-1 Viral Load
Time frame: 4, 8, 12, 16, 20 and 24
Evaluate the effects of adding Ampligen (or no Ampligen) to "HAART" in HIV+ patients for evidence of reductions in HIV-1 viral load in plasma using Roche Amplicor assay.
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 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.
7 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 7 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: stopped early, 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 7 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?
Reduction in HIV-1 Viral Load (time frame: 4, 8, 12, 16, 20 and 24). 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.