HIV InfectionsPhase 1NCT00002198
A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
A Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Local treatment for Kaposi's sarcoma.
- Prophylactic treatment for opportunistic infections.
- Patients must have:
- HIV-1 infection.
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- CD4+ lymphocyte count >= 200 cells/microliter within 14 days prior to study drug administration.
- No active diagnosis of AIDS (other than visceral Kaposi's sarcoma) according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
- Prior Medication:
- Allowed:
- Local treatment for Kaposi's sarcoma.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption.
- Concurrent Medication:
- Excluded:
- Medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day.
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- Immunomodulators, such as systemic corticosteroids, interleukins and interferons.
- Cytotoxic chemotherapeutic agents.
- Acute treatment for opportunistic infections.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- Documented history of alcoholism.
- History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
- History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
- Participation in another research study within the past month.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
- Immunomodulating agents within six weeks prior to study drug administration.
- Treatment with the following within 2 weeks prior to study drug administration:
- acyclovir, carbamazepine, chloramphenicol, ganciclovir, phenytoin, rifampin, sodium valproate, or valacyclovir.
- Prior Treatment:
- Excluded:
- Radiation therapy within 6 weeks prior to study drug administration.
- 1. Regular weekly alcohol intake of more than 21 units (a unit is equal to 1/2 pint beer or 1 glass of wine or 1 oz of liquor).
- Recent change in normal pattern of alcohol usage (e.g., prolonged use followed by > one month abstinence).
- Total abstinence from alcohol use.
- Positive breath alcohol test upon arrival at the study center prior to any dosing day.
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Development, Inc
Wilmington, North Carolina, 28412
About this study
Official title: A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects.
The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.
Read the detailed description
Patients are randomized to one of the following three regimens:
Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate
- Keywords
- Drug Interactions, Antiviral Agents, Ethanol, abacavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfateDrug
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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002198
- Sponsor's protocol ID
- 238F
- Other IDs
- CNAA 1010
- Status last verified
- Aug 1997
- 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 Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects.
- ClinicalTrials.gov ID
- NCT00002198
- Acronym / sponsor ID
- 238F
- Conditions
- HIV Infections
- Keywords
- Drug Interactions, Antiviral Agents, Ethanol, abacavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (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.
The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.
Detailed description
Patients are randomized to one of the following three regimens:
Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Local treatment for Kaposi's sarcoma.
- Prophylactic treatment for opportunistic infections.
- HIV-1 infection.
- CD4+ lymphocyte count >= 200 cells/microliter within 14 days prior to study drug administration.
- No active diagnosis of AIDS (other than visceral Kaposi's sarcoma) according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
Key exclusion criteria (30 listed)
- Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption.
- Medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day.
- Immunomodulators, such as systemic corticosteroids, interleukins and interferons.
- Cytotoxic chemotherapeutic agents.
- Acute treatment for opportunistic infections.
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 |
|---|---|---|
| Abacavir sulfate | 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 Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome 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 11 inclusion and 30 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.
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?
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.