HIV InfectionsPhase 1NCT00000713
A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
A Phase 1 study testing Ampligen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied. Evidence indicates that a long period with no symptoms follows infection with HIV. 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?
- Ampligen
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 1992
- Phase
- Phase 1
- 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:
- Short-course therapy (7 days) with oral acyclovir or ketoconazole.
- Patients must have:
- Evidence of HIV infection as measured by a confirmed positive antibody test.
- A confirmed or pending HIV blood culture, and serum p24 antigen test.
- The ELISA test confirmed by a licensed Western blot analysis if they are asymptomatic.
Who cannot join
- Concurrent Medication:
- Excluded:
- Aspirin or acetaminophen beyond 72 hours without contacting investigator.
- Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
- Patients with the following are excluded:
- AIDS.
Show all 26Show fewer
- AIDS related symptoms or with advanced ARC and < 200 CD4 cells/mm3 and at least two of the following:
- Weight loss in excess of 10 lbs or 10 percent of body weight within a 6-month interval.
- Temperature > 38.5 degrees C with or without night sweats, persisting for more than 14 consecutive days or more than 15 days in a 30-day interval.
- Diarrhea defined as = or > 3 liquid stools per day, persisting for more than 30 days without definable cause.
- Recurrent oral candidiasis as documented by morphology or by response to antifungal therapy.
- Patients cannot have active oral candidiasis at the time of entry into the study; they must be free of candidiasis from baseline 1 to enrollment.
- Multidermatomal herpes zoster within the past 2 years.
- Hairy leukoplakia within the past 3 years.
- Prior Medication:
- Excluded within 14 days of study entry:
- Other biologic response modifiers.
- Corticosteroids.
- Systemic antibiotics.
- Excluded within 30 days of study entry:
- Other antiretroviral agents.
- Excluded within 60 days of study entry:
- Ribavirin.
- Zidovudine.
- Concurrent neoplasms other than basal cell carcinoma of the skin.
- Active drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania
About this study
To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied.
Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Read the detailed description
Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Individuals entered in the study are given ampligen by intravenous infusion once during the first week of the trial and twice a week during the following 8 weeks. The dose each individual receives is determined by the responses of earlier individuals. Each is followed for 12 weeks after the last dose of ampligen is given. Each individual maintains a daily diary listing any symptoms or problems that occur, such as headache, nausea, or change in appetite. Other anti-HIV drugs cannot be taken during the trial, and aspirin or acetaminophen should not be taken for more than 2 hours without consulting the research staff. Blood is drawn at intervals during the trial and follow-up and used to determine the effect of ampligen on the HIV and the immune system as well as to monitor any toxicity and side effects.
- Conditions
- HIV Infections
- Being tested
- Ampligen
- Keywords
- Polyribonucleotides, HIV Seropositivity, Dose-Response Relationship, Drug, Drug Evaluation, Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, HIV Seropositivity, 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.
AmpligenDrug
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 completionOct 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- M Ho, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000713
- Sponsor's protocol ID
- ACTG 038
- Other IDs
- 11014
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Armstrong JA, McMahon D, Huang XL, Pazin GJ, Gupta P, Rinaldo CR Jr, Schoenfeld DA, Gaccione P, Tripoli CA, Bensasi S, et al. A phase I study of ampligen in human immunodeficiency virus-infected subjects. J Infect Dis. 1992 Oct;166(4):717-22. doi: 10.1093/infdis/166.4.717.
PubMed 1527407
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 Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00000713
- Acronym / sponsor ID
- ACTG 038
- Conditions
- HIV Infections
- Keywords
- Polyribonucleotides, HIV Seropositivity, Dose-Response Relationship, Drug, Drug Evaluation, Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 1992 (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 determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied.
Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Detailed description
Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Individuals entered in the study are given ampligen by intravenous infusion once during the first week of the trial and twice a week during the following 8 weeks. The dose each individual receives is determined by the responses of earlier individuals. Each is followed for 12 weeks after the last dose of ampligen is given. Each individual maintains a daily diary listing any symptoms or problems that occur, such as headache, nausea, or change in appetite. Other anti-HIV drugs cannot be taken during the trial, and aspirin or acetaminophen should not be taken for more than 2 hours without consulting the research staff. Blood is drawn at intervals during the trial and follow-up and used to determine the effect of ampligen on the HIV and the immune system as well as to monitor any toxicity and side effects.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Short-course therapy (7 days) with oral acyclovir or ketoconazole.
- Evidence of HIV infection as measured by a confirmed positive antibody test.
- A confirmed or pending HIV blood culture, and serum p24 antigen test.
- The ELISA test confirmed by a licensed Western blot analysis if they are asymptomatic.
Key exclusion criteria (26 listed)
- Aspirin or acetaminophen beyond 72 hours without contacting investigator.
- Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
- AIDS.
- AIDS related symptoms or with advanced ARC and < 200 CD4 cells/mm3 and at least two of the following:
- Weight loss in excess of 10 lbs or 10 percent of body weight within a 6-month interval.
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 |
|---|---|---|
| Ampligen | 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 1527407Armstrong JA, McMahon D, Huang XL, Pazin GJ, Gupta P, Rinaldo CR Jr, Schoenfeld DA, Gaccione P, Tripoli CA, Bensasi S, et al. A phase I study of ampligen in human immunodeficiency virus-infected subjects. J Infect Dis. 1992 Oct;166(4):717-22. doi: 10.1093/infdis/166.4.717.
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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.
M Ho study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ampligen in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 26 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
On the ClinicalTrials.gov record for NCT00000713, which also lists 1 linked publication.
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.