Cytomegalovirus RetinitisPhase 1NCT00000673
A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
A Phase 1 study testing Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis. AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Ganciclovir
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento May 1993
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- AMENDED: 8/8/90 Other available antiretroviral therapy.
- Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized).
- Chemotherapy for Kaposi's sarcoma.
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- Systemic therapy for intercurrent opportunistic infections.
- Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections.
- Systemic therapy deemed necessary for appropriate medical management.
- Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.
- Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.
- Concurrent Medication:
- Excluded:
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- Prophylactic acyclovir at time of study entry.
- Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin.
- Topical ophthalmic medications should be avoided.
- Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection.
- Patients with the following are excluded:
- Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.
- Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univ. of Miami AIDS CRS
Miami, Florida, 33136
Washington U CRS
St Louis, Missouri
About this study
AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis.
AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Nonrandomized eyes will not be used for the primary efficacy evaluation.
Read more
ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection.
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.
Read the detailed description
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.
Patients must have active CMV retinitis in one or both eyes, despite prior systemic therapy. Following medical evaluation, the decision is made whether to treat the eye(s) immediately or to watch the eye(s) carefully for advancement of the retinitis. Eyes with sight-threatening lesions or eyes without functional vision are treated immediately and eyes without sight-threatening lesions are randomly chosen for either immediate or deferred therapy. DHPG is given by injection with a very fine needle twice a week for the first 3 weeks and once a week for the remaining 24 weeks.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Ganciclovir
- Keywords
- Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, AIDS-Related Opportunistic 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.
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 completionMay 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 38 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Polsky B, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000673
- Sponsor's protocol ID
- ACTG 085
- Other IDs
- 11060
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 27 Oct 2021
- Results posted
- No
Publications
Polsky B, Wolitz R, Cantrill H, Chuang EL, Heinemann MH, Sands M, Feinberg JE, Power M, Davis R. Intravitreal (IVL) Ganciclovir (GCV) salvage therapy (Rx) for cytomegalovirus (CMV) retinitis (ACTG 085): a preliminary report. Int Conf AIDS. 1991 Jun 16-21;7(2):267 (abstract no WB2340)
Polsky, et al. Intravitreal ganciclovir salvage therapy for cytomegalovirus retinitis in AIDS: AIDS Clinical Trials Groups Protocol 085. Int J Infect Dis. 1996 Oct; 1(2):70-4
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
- ClinicalTrials.gov ID
- NCT00000673
- Acronym / sponsor ID
- ACTG 085
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 1993 (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.
AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis.
AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Nonrandomized eyes will not be used for the primary efficacy evaluation.
ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection.
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.
Detailed description
CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.
Patients must have active CMV retinitis in one or both eyes, despite prior systemic therapy. Following medical evaluation, the decision is made whether to treat the eye(s) immediately or to watch the eye(s) carefully for advancement of the retinitis. Eyes with sight-threatening lesions or eyes without functional vision are treated immediately and eyes without sight-threatening lesions are randomly chosen for either immediate or deferred therapy. DHPG is given by injection with a very fine needle twice a week for the first 3 weeks and once a week for the remaining 24 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Zidovudine (AZT).
- AMENDED: 8/8/90 Other available antiretroviral therapy.
- Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized).
- Chemotherapy for Kaposi's sarcoma.
- Systemic therapy for intercurrent opportunistic infections.
Key exclusion criteria (13 listed)
- Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.
- Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.
- Prophylactic acyclovir at time of study entry.
- Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin.
- Topical ophthalmic medications should be avoided.
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 |
|---|---|---|
| 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 27 Oct 2021.
- BackgroundPolsky B, Wolitz R, Cantrill H, Chuang EL, Heinemann MH, Sands M, Feinberg JE, Power M, Davis R. Intravitreal (IVL) Ganciclovir (GCV) salvage therapy (Rx) for cytomegalovirus (CMV) retinitis (ACTG 085): a preliminary report. Int Conf AIDS. 1991 Jun 16-21;7(2):267 (abstract no WB2340)
- BackgroundPolsky, et al. Intravitreal ganciclovir salvage therapy for cytomegalovirus retinitis in AIDS: AIDS Clinical Trials Groups Protocol 085. Int J Infect Dis. 1996 Oct; 1(2):70-4
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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.
Polsky B study chair
2 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 Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 10 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 NCT00000673, which also lists 2 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 27 Oct 2021.