HIV InfectionsNCT00002266
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
A study testing AS-101 in people with HIV Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- AS-101
- How many people
- Not given
- Where
- 1 siteUnited 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Standard therapy for infections.
- Acyclovir.
- Ganciclovir.
- Allowed only with permission of Wyeth-Ayerst medical monitor:
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- Zidovudine (AZT).
- Immunomodulators.
- Specific therapy for malignancies (including Kaposi's sarcoma).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
- Evidence of AIDS-related central nervous system involvement.
- Disseminated Kaposi's sarcoma.
- Concurrent Medication:
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- Excluded without permission of Wyeth-Ayerst medical monitor:
- Zidovudine (AZT).
- Immunomodulators.
- Specific therapy for malignancies (including Kaposi's sarcoma).
- Patients with the following are excluded:
- Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
- Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
- Unlikely or unable to comply with the requirements of the protocol.
- Prior Medication:
- Excluded within 4 weeks of study entry:
- Systemic antiviral agents.
- Immunosuppressive agents.
- Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.
- Patients must:
- Have a diagnosis of AIDS or AIDS related complex (ARC).
- Demonstrate intolerance or refusal to take zidovudine (AZT).
- Provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
About this study
To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.
- Conditions
- HIV Infections
- Being tested
- AS-101
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute
- 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.
AS-101Drug
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
- None (open label)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002266
- Sponsor's protocol ID
- 045B
- Other IDs
- 753A-103-US
- Status last verified
- Dec 1990
- 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
- An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
- ClinicalTrials.gov ID
- NCT00002266
- Acronym / sponsor ID
- 045B
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (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 compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Standard therapy for infections.
- Acyclovir.
- Ganciclovir.
- Allowed only with permission of Wyeth-Ayerst medical monitor:
- Zidovudine (AZT).
Key exclusion criteria (23 listed)
- Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
- Evidence of AIDS-related central nervous system involvement.
- Disseminated Kaposi's sarcoma.
- Zidovudine (AZT).
- Immunomodulators.
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 |
|---|---|---|
| AS-101 | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AS-101 in people with HIV Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer 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 9 inclusion and 23 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 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.
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.