Cytomegalovirus InfectionsNCT00002352
A Study of Lobucavir in Patients With AIDS
A study testing Lobucavir in people with Cytomegalovirus Infections and HIV Infections, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, HIV Infections
- What is being tested?
- Lobucavir
- How many people
- 30 participants
- Where
- 3 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
- Concurrent Medication:
- Allowed:
- Aerosolized pentamidine.
- TMP / SMX.
- Isoniazid.
- Dapsone.
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- Fluconazole.
- Ketoconazole.
- Rifabutin.
- Fluoxetine HCl.
- Acetaminophen.
- Antacids.
- Metamucil.
- Multivitamins.
- Other drugs with approval from sponsor.
- Patients must have:
- AIDS.
- CD4 count < 200 cells/mm3.
- Cytomegalovirus ( CMV ) viruria and virosemenia.
- No evidence of intraocular CMV.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness.
- Inability to take oral medication.
- Allergy to nucleoside analogs.
- Diarrheal illness.
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- Poor venous access.
- Positive test for drugs of abuse.
- Any other condition that would render patient unsuitable for study.
- Patients with the following prior conditions are excluded:
- History of pancreatitis.
- Recent diarrheal illness.
- History of weight loss.
- Acute serious illness within 4 weeks prior to study entry.
- Prior Medication:
- Excluded within 4 weeks prior to study entry:
- Erythropoietin.
- Any agent with anti-CMV activity.
- Other investigational agents.
- Prior Treatment:
- Excluded within 4 weeks prior to study entry:
- Surgery.
- Blood transfusion. Drug abuse.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Univ of Minnesota
Minneapolis, Minnesota, 55455
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
About this study
Official title: Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.
Read the detailed description
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Being tested
- Lobucavir
- Keywords
- Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents
- Medical subject headings
- Cytomegalovirus Infections, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LobucavirDrug
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 Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002352
- Sponsor's protocol ID
- 248A
- Other IDs
- AI459-007
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 1999
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Antiviral Activity of Multiple Doses of Oral Lobucavir in AIDS Patients
- ClinicalTrials.gov ID
- NCT00002352
- Acronym / sponsor ID
- 248A
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Keywords
- Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (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 if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.
Detailed description
Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.
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 (20 listed)
- Aerosolized pentamidine.
- TMP / SMX.
- Isoniazid.
- Dapsone.
- Fluconazole.
Key exclusion criteria (23 listed)
- Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness.
- Inability to take oral medication.
- Allergy to nucleoside analogs.
- Diarrheal illness.
- Poor venous access.
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 |
|---|---|---|
| Lobucavir | 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 2 Oct 2007.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lobucavir in people with Cytomegalovirus Infections and HIV Infections, run by Bristol-Myers Squibb at 3 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 20 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 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 Oct 2007.