Cytomegalovirus RetinitisNCT00000799
HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
A study testing Cidofovir and Probenecid in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens. 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?
- Cidofovir and Probenecid
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento Apr 1996
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
- Fluconazole.
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- Ketoconazole.
- Itraconazole.
- Rifabutin.
- Filgrastim (G-CSF).
- Antiretroviral agents.
- Patients must have:
- AIDS by CDC criteria.
- CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field.
- Prior Medication:
- Allowed:
- Prophylaxis with anti-CMV agents.
Who cannot join
- Concurrent Medication:
- Excluded:
- Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
- Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.
- Patients with the following prior conditions are excluded:
- History of renal disease or renal dialysis.
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- History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- History of clinically significant probenecid allergy.
- Prior Medication:
- Excluded:
- Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
- Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.
- Drug or alcohol abuse sufficient to hinder compliance with study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, 212879217
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030
Northwestern Univ / SOCA
Chicago, Illinois, 60611
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, 920930946
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, 900957003
New York Univ Med Ctr / SOCA
New York, New York, 10016
UCSF - San Francisco Gen Hosp
San Francisco, California, 94143
About this study
To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
Read the detailed description
In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Cidofovir, Probenecid
- Keywords
- Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CidofovirDrug
ProbenecidDrug
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 completionApr 1996
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000799
- Sponsor's protocol ID
- ACTG 281
- Other IDs
- GS-93-105, FDA 231A
- Status last verified
- Oct 2012
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2012
- Results posted
- No
Publications
Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.
PubMed 9036798
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
- ClinicalTrials.gov ID
- NCT00000799
- Acronym / sponsor ID
- ACTG 281
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Gilead Sciences
- Study completion
- Apr 1996 (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 short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
Detailed description
In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.
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 (17 listed)
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
- Fluconazole.
- Ketoconazole.
Key exclusion criteria (13 listed)
- Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
- Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.
- History of renal disease or renal dialysis.
- History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- History of clinically significant probenecid allergy.
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 |
|---|---|---|
| Cidofovir | Drug | – |
| Probenecid | 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 2012.
- Background: PubMed 9036798Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cidofovir and Probenecid in people with Cytomegalovirus Retinitis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 17 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 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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 NCT00000799, 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 1 Nov 2012.