Cytomegalovirus RetinitisPhase 3NCT00002070
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
A Phase 3 study testing Sargramostim and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Schering-Plough at 14 sites in United States.
Trial summary
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Sargramostim and Ganciclovir
- How many people
- Not given
- Where
- 14 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Patient must have the following:
- AIDS as defined by CDC criteria.
- Retinitis as diagnosed by the study ophthalmologist.
- Performance status 0, 1, or 2.
- Ability to give informed consent and suitability of intravenous access for scheduled blood tests.
- Patient may have Kaposi's sarcoma or basal skin cancer.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Active acute infection requiring treatment.
- Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
- Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.
- Patients with the following are excluded:
Show all 27Show fewer
- Active acute infection requiring treatment.
- Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
- Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.
- Prior Medication:
- Excluded:
- Granulocyte macrophage colony-stimulating factor (GM-CSF).
- Colony stimulating factor.
- Interleukin 3.
- Excluded within 7 days of study entry:
- Zidovudine (AZT).
- Trimethoprim / sulfamethoxazole (TMP / SMX).
- Pyrimethamine.
- Excluded within 30 days of study entry:
- Biologic response modifiers.
- Cytotoxic agents.
- Investigational agents.
- Prior Treatment:
- Excluded:
- Radiation therapy.
- Required within 1 week of study entry:
- One or more doses of ganciclovir.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Methodist Hosp
Houston, Texas, 77030
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
UCLA CARE Ctr
Los Angeles, California, 90095
Cabrini Med Ctr
New York, New York, 10003
Dr Douglas Dieterich
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hosp of San Francisco
San Francisco, California, 94118
Pacific Presbyterian
San Francisco, California, 94118
Gottlieb Med Group
Sherman Oaks, California, 91403
About this study
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Sargramostim, Ganciclovir
- Keywords
- Recombinant Proteins, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, Ganciclovir, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, 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.
SargramostimDrug
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.
- Other trials for Cytomegalovirus RetinitisStudies 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002070
- Sponsor's protocol ID
- 005A
- Other IDs
- C88-059
- Status last verified
- May 1991
- 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
- Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
- ClinicalTrials.gov ID
- NCT00002070
- Acronym / sponsor ID
- 005A
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Recombinant Proteins, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, Ganciclovir, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Cytomegalovirus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Schering-PloughIndustry (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 co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
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 (6 listed)
- AIDS as defined by CDC criteria.
- Retinitis as diagnosed by the study ophthalmologist.
- Performance status 0, 1, or 2.
- Ability to give informed consent and suitability of intravenous access for scheduled blood tests.
- Patient may have Kaposi's sarcoma or basal skin cancer.
Key exclusion criteria (27 listed)
- Active acute infection requiring treatment.
- Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
- Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.
- Active acute infection requiring treatment.
- Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
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 |
|---|---|---|
| Sargramostim | 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.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sargramostim and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Schering-Plough at 14 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 6 inclusion and 27 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 14 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.