Cytomegalovirus RetinitisPhase 2NCT00001061
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
A Phase 2 study testing Sevirumab, Foscarnet sodium and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in United States.
Trial summary
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Sevirumab, Foscarnet sodium and Ganciclovir
- How many people
- 167 participants
- Where
- 20 sitesUnited States
- Study dates
- Start not givento Mar 1998
- Phase
- Phase 2
- 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:
- Allowed:
- G-CSF and GM-CSF.
- Antiretroviral therapy.
- Patients must have:
- HIV infection.
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- First episode of CMV retinitis.
- No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible.
- No active AIDS-defining opportunistic infection or malignancy that requires nephrotoxic or myelosuppressive therapy.
- Life expectancy of at least 6 months.
- Consent of parent or guardian if less than 18 years of age.
- NOTE:
- This protocol is approved for prisoner participation.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted).
- Corneal, lens, or vitreous opacification that precludes funduscopic exam.
- Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.)
- Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression.
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- Known hypersensitivity to the study drugs.
- PER AMENDMENT 4/25/96:
- Presence of CMV retinal lesions that are only in areas of the retina which cannot be photographed.
- Concurrent Medication:
- Excluded:
- Immunomodulators, biologic response modifiers, interferon, or investigational agents that may influence course of CMV infection.
- Systemic acyclovir or any nephrotoxic agent, specifically aminoglycosides, amphotericin B, and parenteral pentamidines.
- Any concomitant therapy that would preclude use of cidofovir, foscarnet or ganciclovir.
- Prior Medication:
- Excluded: PER AMENDMENT 4/25/96:
- Use of IV ganciclovir, foscarnet or cidofovir within 6 months prior to study enrollment. (Was written - Ganciclovir or foscarnet for non-CMV herpes infections within 6 months prior to study entry.)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405
Case CRS
Cleveland, Ohio, 44106
Queens Med. Ctr.
Honolulu, Hawaii, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250
USC CRS
Los Angeles, California, 900331079
Univ. of Miami AIDS CRS
Miami, Florida, 331361013
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Santa Clara Valley Med. Ctr.
San Jose, California, 951282699
Washington U CRS
St Louis, Missouri
Stanford CRS
Stanford, California, 943055107
About this study
Official title: A Phase II, Double-Masked, Randomized, Placebo-Controlled Evaluation of Standard Therapy vs. Standard Therapy Combined With Human Monoclonal Anti-Cytomegalovirus Antibody (MSL 109) in the Therapy of AIDS Patients With Cytomegalovirus (CMV) Retinitis
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers.
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
Read the detailed description
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days, then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression. Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance. They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks. Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs. AS PER AMENDMENT 11/29/96: Enrollment onto the current study has been discontinued. To study the enhancement of humoral immunity, a high-dose cohort has been added. Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before. Randomization is weighted 2:1 in favor of high-dose MSL 109. Interim analyses will be performed to provide for early discontinuation, as indicated. Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Sevirumab, Foscarnet sodium, Ganciclovir
- Keywords
- AIDS-Related Opportunistic Infections, Ganciclovir, Foscarnet, Acquired Immunodeficiency Syndrome, Antibodies, Monoclonal, Cytomegalovirus Retinitis
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, AIDS-Related Opportunistic 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.
SevirumabDrug
Foscarnet sodiumDrug
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 completionMar 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus RetinitisStudies 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 2
- Primary purpose
- Treatment
- Enrolment
- 167 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Facet Biotech
- Responsible party
- Sponsor
- Investigators
- Pollard RB, Study chairBorucki M, Study chairGnann J, Study chairHirsch MS, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001061
- Sponsor's protocol ID
- ACTG 266
- Other IDs
- 11242
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Borucki M, Spritzler J, Gnann J, Hirsch M, Nokta M, Aweeka F, Pollard R. A phase II double masked, placebo-controlled evaluation of standard therapy vs standard therapy combined with human monoclonal anti-cytomegalovirus antibody (MSL-109) in the therapy of AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis in ACTG 266. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:154 (abstract no 460)
CMV retinitis study aborted. GMHC Treat Issues. 1996 Sep;10(9):8.
PubMed 11363844Borucki MJ, Spritzler J, Asmuth DM, Gnann J, Hirsch MS, Nokta M, Aweeka F, Nadler PI, Sattler F, Alston B, Nevin TT, Owens S, Waterman K, Hubbard L, Caliendo A, Pollard RB; AACTG 266 Team. A phase II, double-masked, randomized, placebo-controlled evaluation of a human monoclonal anti-Cytomegalovirus antibody (MSL-109) in combination with standard therapy versus standard therapy alone in the treatment of AIDS patients with Cytomegalovirus retinitis. Antiviral Res. 2004 Nov;64(2):103-11. doi: 10.1016/j.antiviral.2004.06.012.
PubMed 15498605
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Masked, Randomized, Placebo-Controlled Evaluation of Standard Therapy vs. Standard Therapy Combined With Human Monoclonal Anti-Cytomegalovirus Antibody (MSL 109) in the Therapy of AIDS Patients With Cytomegalovirus (CMV) Retinitis
- ClinicalTrials.gov ID
- NCT00001061
- Acronym / sponsor ID
- ACTG 266
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Ganciclovir, Foscarnet, Acquired Immunodeficiency Syndrome, Antibodies, Monoclonal, Cytomegalovirus Retinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Facet Biotech
- Study completion
- Mar 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 evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers.
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
Detailed description
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days, then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression. Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance. They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks. Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs. AS PER AMENDMENT 11/29/96: Enrollment onto the current study has been discontinued. To study the enhancement of humoral immunity, a high-dose cohort has been added. Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before. Randomization is weighted 2:1 in favor of high-dose MSL 109. Interim analyses will be performed to provide for early discontinuation, as indicated. Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- G-CSF and GM-CSF.
- Antiretroviral therapy.
- HIV infection.
- First episode of CMV retinitis.
- No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible.
Key exclusion criteria (17 listed)
- PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted).
- Corneal, lens, or vitreous opacification that precludes funduscopic exam.
- Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.)
- Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression.
- Known hypersensitivity to the study drugs.
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 |
|---|---|---|
| Sevirumab | Drug | – |
| Foscarnet sodium | 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 1 Nov 2021.
- BackgroundBorucki M, Spritzler J, Gnann J, Hirsch M, Nokta M, Aweeka F, Pollard R. A phase II double masked, placebo-controlled evaluation of standard therapy vs standard therapy combined with human monoclonal anti-cytomegalovirus antibody (MSL-109) in the therapy of AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis in ACTG 266. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:154 (abstract no 460)
- Background: PubMed 11363844CMV retinitis study aborted. GMHC Treat Issues. 1996 Sep;10(9):8.
- Results publication: PubMed 15498605Borucki MJ, Spritzler J, Asmuth DM, Gnann J, Hirsch MS, Nokta M, Aweeka F, Nadler PI, Sattler F, Alston B, Nevin TT, Owens S, Waterman K, Hubbard L, Caliendo A, Pollard RB; AACTG 266 Team. A phase II, double-masked, randomized, placebo-controlled evaluation of a human monoclonal anti-Cytomegalovirus antibody (MSL-109) in combination with standard therapy versus standard therapy alone in the treatment of AIDS patients with Cytomegalovirus retinitis. Antiviral Res. 2004 Nov;64(2):103-11. doi: 10.1016/j.antiviral.2004.06.012.
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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.
Pollard RB study chair
Borucki M study chair
Gnann J study chair
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sevirumab, Foscarnet sodium and Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 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 13 inclusion and 17 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 1 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 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00001061, which also lists 3 linked publications.
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 1 Nov 2021.