ColitisPhase 1NCT00000768
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
A Phase 1 study testing Glutamic acid hydrochloride and Ganciclovir in people with Colitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these regimens to that of standard intravenous (IV) ganciclovir. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Colitis, HIV Infections
- What is being tested?
- Glutamic acid hydrochloride and Ganciclovir
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento Aug 1998
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Recommended:
- PCP prophylaxis.
- Allowed:
- Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
- Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
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- Recombinant human erythropoietin.
- GM-CSF and G-CSF.
- Other medications necessary for patient's welfare, at the physician's discretion.
- Patients must have:
- HIV infection.
- Biopsy-proven cytomegalovirus (CMV) colitis.
- Life expectancy of at least 3 months.
- No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.
- NOTE:
- Kaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Other etiologies for diarrhea identified at study entry.
- PER AMENDMENT 3/14/95:
- For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
- Known hypersensitivity to study drugs.
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- CMV retinitis.
- Concurrent Medication:
- Excluded:
- Acyclovir or probenecid (PER AMENDMENT 3/14/95).
- Immunomodulators.
- Biologic response modifiers (other than GM-CSF or G-CSF).
- Investigational agents, with the exception of treatment IND drugs.
- Antacids.
- H2 blockers.
- Proton pump inhibitors.
- Foscarnet during induction and pharmacokinetic part of study.
- Intravenous CMV retinitis maintenance therapy (including ganciclovir) during pharmacokinetic part of study.
- Nephrotoxic agents.
- Prior Medication:
- Excluded within 14 days prior to study entry:
- Immunomodulators.
- Biologic response modifiers (other than GM-CSF or G-CSF).
- Investigational agents, with the exception of treatment IND drugs.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Ucsf Aids Crs
San Francisco, California
Washington U CRS
St Louis, Missouri
About this study
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these regimens to that of standard intravenous (IV) ganciclovir.
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
Read the detailed description
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 (Per Amendment 3/4/95) days. A permanent venous catheter is implanted for the induction therapy. If clinically improved following induction, patients are then randomized to receive one of three doses of oral ganciclovir, given first without and then with oral glutamic acid hydrochloride, every 8 hours until they reach a steady state. PER AMENDMENT 3/14/95: After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken. Subjects will continue the dosing regimen they were assigned to (glutamic acid hydrochloride will be added if it resulted in at least 33% increased bioavailability) for up to 12 months or until relapse of CMV GI disease is documented. Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse. Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse.
- Conditions
- Colitis, HIV Infections
- Being tested
- Glutamic acid hydrochloride, Ganciclovir
- Keywords
- Intestinal Absorption, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Colitis, Administration, Oral, Acquired Immunodeficiency Syndrome, Biological Availability, Glutamic Acid
- Medical subject headings
- Colitis, HIV Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamic acid hydrochlorideDrug
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)
- Study completionAug 1998
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 ColitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Allocation
- Randomised
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Jacobson M, Study chairDieterich D, Study chairKotler D, Study chairLaine L, Study chairKumar P, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000768
- Sponsor's protocol ID
- ACTG 183
- Other IDs
- 11158
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Dieterich DT, Kotler DP, Busch DF, Crumpacker C, Du Mond C, Dearmand B, Buhles W. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis. 1993 Feb;167(2):278-82. doi: 10.1093/infdis/167.2.278.
PubMed 8380610
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
- ClinicalTrials.gov ID
- NCT00000768
- Acronym / sponsor ID
- ACTG 183
- Conditions
- Colitis, HIV Infections
- Keywords
- Intestinal Absorption, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Colitis, Administration, Oral, Acquired Immunodeficiency Syndrome, Biological Availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Study completion
- Aug 1998 (actual)
- 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 the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these regimens to that of standard intravenous (IV) ganciclovir.
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
Detailed description
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 (Per Amendment 3/4/95) days. A permanent venous catheter is implanted for the induction therapy. If clinically improved following induction, patients are then randomized to receive one of three doses of oral ganciclovir, given first without and then with oral glutamic acid hydrochloride, every 8 hours until they reach a steady state. PER AMENDMENT 3/14/95: After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken. Subjects will continue the dosing regimen they were assigned to (glutamic acid hydrochloride will be added if it resulted in at least 33% increased bioavailability) for up to 12 months or until relapse of CMV GI disease is documented. Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse. Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- PCP prophylaxis.
- Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
- Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
- Recombinant human erythropoietin.
- GM-CSF and G-CSF.
Key exclusion criteria (24 listed)
- Other etiologies for diarrhea identified at study entry.
- For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
- Known hypersensitivity to study drugs.
- CMV retinitis.
- Acyclovir or probenecid (PER AMENDMENT 3/14/95).
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 |
|---|---|---|
| Glutamic acid hydrochloride | 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 4 Nov 2021.
- Background: PubMed 8380610Dieterich DT, Kotler DP, Busch DF, Crumpacker C, Du Mond C, Dearmand B, Buhles W. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis. 1993 Feb;167(2):278-82. doi: 10.1093/infdis/167.2.278.
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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.
Jacobson M study chair
Dieterich D study chair
Kotler D study chair
5 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 Glutamic acid hydrochloride and Ganciclovir in people with Colitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 16 inclusion and 24 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 NCT00000768, 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 4 Nov 2021.