Cytomegalovirus RetinitisNCT00001999
A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
A study testing Globulin, Immune and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by American National Red Cross at 1 site in United States.
Trial summary
To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). 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?
- Globulin, Immune and Ganciclovir
- How many people
- Not given
- Where
- 1 siteUnited 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
- Patients must have the following:
- First episode of sight-threatening CMV retinitis.
- At least one pending culture for CMV from the blood or urine prior to entry.
- Life expectancy > 6 months.
- Karnofsky performance = or > 60.
- Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Known selective IGA deficiency or antibodies against IgA.
- History of previous episodes of sight-threatening CMV retinitis.
- Patients with the following are excluded:
- Previous episode of sight-threatening CMV retinitis.
Show all 13Show fewer
- Concomitant treatment with other investigational agents except ddI or ddC.
- Life expectancy < 6 months.
- Continued alcohol or drug abuse.
- Known selective IgA deficiency and known to have antibodies against IgA.
- Karnofsky performance <60.
- Other investigational agents except ddI or ddC.
- ddI ddC
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
About this study
To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Globulin, Immune, Ganciclovir
- Keywords
- Retinitis, Gamma-Globulins, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunization, Passive
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, 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.
Globulin, ImmuneDrug
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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- American National Red Cross
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001999
- Sponsor's protocol ID
- 079A
- Other IDs
- 219-90
- Status last verified
- Apr 1993
- 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 Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
- ClinicalTrials.gov ID
- NCT00001999
- Acronym / sponsor ID
- 079A
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Gamma-Globulins, Ganciclovir, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunization, Passive
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- American National Red CrossUniversity, hospital or other
- 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 evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.
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)
- First episode of sight-threatening CMV retinitis.
- At least one pending culture for CMV from the blood or urine prior to entry.
- Life expectancy > 6 months.
- Karnofsky performance = or > 60.
- Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent.
Key exclusion criteria (13 listed)
- Known selective IGA deficiency or antibodies against IgA.
- History of previous episodes of sight-threatening CMV retinitis.
- Previous episode of sight-threatening CMV retinitis.
- Concomitant treatment with other investigational agents except ddI or ddC.
- Life expectancy < 6 months.
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 |
|---|---|---|
| Globulin, Immune | 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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CMV Retinitis
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Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Cytomegalovirus Retinitis, Ganciclovir Eye Drops
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 study testing Globulin, Immune and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by American National Red Cross 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 6 inclusion and 13 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.
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.