HIV InfectionsNCT00002269
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
A study testing Ampligen and Zidovudine in people with HIV Infections, run by HEM Research at 5 sites in United States.
Trial summary
To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3. 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 and Zidovudine
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV-1 seropositivity.
- Absolute number of T4 cells 100-300 cells/mm3.
- Given informed consent.
- Zidovudine (AZT) therapy for 6 months prior to study entry.
- At least one of the listed HIV-related clinical symptoms or opportunistic infections:
- weight loss > 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis > 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Evidence of AIDS.
- Intercurrent acute medical disorder.
- Concurrent Medication:
- Excluded:
Show all 20Show fewer
- Chemotherapy for Kaposi's sarcoma (KS).
- Aspirin.
- Non-steroidal anti-inflammatory drugs.
- Patients with the following are excluded:
- Inability to return for treatment and evaluation for 12 months.
- Intercurrent acute medical disorder.
- Evidence of AIDS.
- Receiving chemotherapy for Kaposi's sarcoma (KS).
- Unwilling or unable to give informed consent.
- Required:
- Zidovudine (AZT).
- Required at least 6 months prior to study entry:
- Zidovudine (AZT).
- Active drug abuse.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Nelson Tebedo Community Clinic
Dallas, Texas, 75219
Dr Patricia Salvato
Houston, Texas, 77054
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
Oregon Health Sciences Univ
Portland, Oregon, 97201
About this study
To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.
- Conditions
- HIV Infections
- Being tested
- Ampligen, Zidovudine
- Keywords
- Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Zidovudine
- 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.
AmpligenDrug
ZidovudineDrug
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)
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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- HEM Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002269
- Sponsor's protocol ID
- 073A
- Other IDs
- AMP-700
- Status last verified
- Aug 1991
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
- ClinicalTrials.gov ID
- NCT00002269
- Acronym / sponsor ID
- 073A
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- HEM ResearchIndustry (pharma, biotech, devices)
- 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 ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 seropositivity.
- Absolute number of T4 cells 100-300 cells/mm3.
- Given informed consent.
- Zidovudine (AZT) therapy for 6 months prior to study entry.
- At least one of the listed HIV-related clinical symptoms or opportunistic infections:
Key exclusion criteria (20 listed)
- Evidence of AIDS.
- Intercurrent acute medical disorder.
- Chemotherapy for Kaposi's sarcoma (KS).
- Aspirin.
- Non-steroidal anti-inflammatory drugs.
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 | – |
| Zidovudine | 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ampligen and Zidovudine in people with HIV Infections, run by HEM Research at 5 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 20 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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 24 Jun 2005.