HIV InfectionsNCT00002013
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
A study testing Zidovudine and 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 evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC). 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?
- Zidovudine and 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:
- Required:
- Zidovudine (AZT).
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
- Standard therapy for infections that develop during the study period.
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- Oral acyclovir.
- Nystatin.
- Ketoconazole.
- Immunomodulators.
- Specific therapy for malignancies (including Kaposi's sarcoma).
- Patients must have the following:
- Diagnosis of AIDS or AIDS related complex (ARC).
- Provide informed written consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Active opportunistic infection or malignancy requiring treatment at study entry.
- Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
- Evidence of central nervous system (CNS) opportunistic infection or malignancy.
- Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
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- Dementia.
- Evidence of = or > 2 + proteinuria at study entry.
- Concurrent Medication:
- Excluded without permission of the Wyeth-Ayerst medical monitor:
- Immunomodulators.
- Specific therapy for malignancies (including Kaposi's sarcoma).
- Patients with the following are excluded:
- Active opportunistic infection or malignancy requiring treatment at study entry.
- Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
- Evidence of conditions listed in the Patient Exclusion Co-existing Conditions.
- Active substance abuse.
- Unlikely or unable to comply with the requirements of the protocol.
- Prior Medication:
- Excluded within 8 weeks of study entry:
- Immunomodulators.
- Antiviral therapy, except zidovudine.
- Excluded within 2 weeks of study entry:
- Intravenous or oral acyclovir.
- Excluded within 3 months of study entry:
- Ribavirin.
- Required:
- Zidovudine at a dose of = or > 1000 mg/day for at least 6 weeks prior to study entry.
- Active substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County - USC Med Ctr
Los Angeles, California, 900331084
About this study
To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
- Conditions
- HIV Infections
- Being tested
- Zidovudine, AS-101
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute, 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.
ZidovudineDrug
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
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
- NCT00002013
- Sponsor's protocol ID
- 045C
- Other IDs
- 753A-109-US
- Status last verified
- Dec 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Laporate JP, Frottier J, Dormont D, Imbert JC, Albeck M, Najman A. As 101 in association with azt in AIDS patients: a phase I pilot study. Int Conf AIDS. 1989 Jun 4-9;5:405 (abstract no WBP320)
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 Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
- ClinicalTrials.gov ID
- NCT00002013
- Acronym / sponsor ID
- 045C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute, Zidovudine
- 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 evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Zidovudine (AZT).
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
- Standard therapy for infections that develop during the study period.
- Oral acyclovir.
Key exclusion criteria (29 listed)
- Active opportunistic infection or malignancy requiring treatment at study entry.
- Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
- Evidence of central nervous system (CNS) opportunistic infection or malignancy.
- Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
- Dementia.
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 |
|---|---|---|
| Zidovudine | Drug | – |
| 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.
- BackgroundLaporate JP, Frottier J, Dormont D, Imbert JC, Albeck M, Najman A. As 101 in association with azt in AIDS patients: a phase I pilot study. Int Conf AIDS. 1989 Jun 4-9;5:405 (abstract no WBP320)
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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 Zidovudine and 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 14 inclusion and 29 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?
On the ClinicalTrials.gov record for NCT00002013, 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 24 Jun 2005.