Cytomegalovirus InfectionsPhase 1NCT00002096
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
A Phase 1 study testing Zidovudine, Didanosine and Ganciclovir in people with Cytomegalovirus Infections and HIV Infections, run by Hoffmann-La Roche at 3 sites in United States.
Trial summary
To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. 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?
- Zidovudine, Didanosine and Ganciclovir
- How many people
- 24 participants
- Where
- 3 sitesUnited 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Required:
- Concomitant AZT or ddI.
- Allowed:
- Probenecid.
- Aerosolized pentamidine.
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- Patients must have:
- Asymptomatic HIV infection.
- CMV seropositivity or CMV culture positivity at present or at any time in the past.
- No history of CMV disease (e.g., retinitis, colitis) or any other AIDS-defining illness.
- Treatment with AZT or ddI for at least 1 month prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Uncontrolled diarrhea (three or more loose stools/day).
- Clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
- AZT patients only:
- Deficiency in glucose-6-phosphate dehydrogenase.
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- ddI patients only:
- Grade 2 or worse peripheral neuropathy.
- Concurrent Medication:
- Excluded:
- Combination antiretroviral therapy.
- G-CSF or GM-CSF.
- Acyclovir.
- Amphotericin B.
- Amikacin.
- Captopril.
- Carbamazepine.
- Cimetidine.
- Cyclosporine.
- Glutethimide.
- Gentamicin.
- Griseofulvin.
- Ibuprofen.
- Imipenem-Cilastatin.
- Lithium.
- Methicillin.
- Methotrexate.
- Naproxen.
- Pentamidine (Pentam 300) (Aerosolized drug permitted).
- Phenacetin.
- Phenobarbital.
- Phenytoin.
- Piroxicam.
- Ribavirin.
- Rifampin.
- Tobramycin.
- Vidarabine.
- Zalcitabine.
- Other investigational drugs.
- Patients with the following prior conditions are excluded:
- History of hypersensitivity to acyclovir or ganciclovir.
- AZT patients only:
- History of gout, uric acid, kidney stones, peptic ulcer or porphyria.
- ddI patients only:
- History of pancreatitis or alcoholism, or seizures within 6 months prior to study entry or prior need for anticonvulsant therapy.
- Prior Medication:
- Excluded:
- Combination antiretroviral therapy within 1 month prior to study entry.
- Required:
- AZT at 500 mg/day for at least 1 month prior to study entry (with 100 mg administered five times per day for at least 1 week prior to study entry). OR
- ddI at recommended dose for at least 1 month prior to study entry (with 250 mg administered every 12 hours for at least 1 week prior to study entry).
- History of alcoholism (in ddI patients).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Ctr for Special Immunology
Irvine, California, 92718
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.
Read the detailed description
Patients currently on either AZT or ddI receive ganciclovir therapy.
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Being tested
- Zidovudine, Didanosine, Ganciclovir
- Keywords
- Didanosine, Ganciclovir, Drug Interactions, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- Cytomegalovirus Infections, HIV Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
DidanosineDrug
GanciclovirDrug
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 Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 1
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002096
- Sponsor's protocol ID
- 059E
- Other IDs
- ICM 1776
- Status last verified
- Nov 1993
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Gaines K, Wong R, Jung D, Cimoch P, Lavelle J, Pollard R. Pharmacokinetic interactions with oral ganciclovir: zidovudine, didanosine, probenecid. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 004B)
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 Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
- ClinicalTrials.gov ID
- NCT00002096
- Acronym / sponsor ID
- 059E
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Keywords
- Didanosine, Ganciclovir, Drug Interactions, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Zidovudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (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 determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.
Detailed description
Patients currently on either AZT or ddI receive ganciclovir therapy.
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 (11 listed)
- Concomitant AZT or ddI.
- Probenecid.
- Aerosolized pentamidine.
- Asymptomatic HIV infection.
- CMV seropositivity or CMV culture positivity at present or at any time in the past.
Key exclusion criteria (52 listed)
- Uncontrolled diarrhea (three or more loose stools/day).
- Clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
- AZT patients only:
- Deficiency in glucose-6-phosphate dehydrogenase.
- ddI patients only:
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 | – |
| Didanosine | Drug | – |
| Ganciclovir | 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.
- BackgroundGaines K, Wong R, Jung D, Cimoch P, Lavelle J, Pollard R. Pharmacokinetic interactions with oral ganciclovir: zidovudine, didanosine, probenecid. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 004B)
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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 Phase 1 study testing Zidovudine, Didanosine and Ganciclovir in people with Cytomegalovirus Infections and HIV Infections, run by Hoffmann-La Roche 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 11 inclusion and 52 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 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.
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?
On the ClinicalTrials.gov record for NCT00002096, 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.