Cytomegalovirus RetinitisNCT00002142
An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS
A study testing Cidofovir and Probenecid in people with Cytomegalovirus Retinitis and HIV Infections, run by Gilead Sciences at 1 site in United States.
Trial summary
To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity. 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
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretroviral agents.
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
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- Fluconazole.
- Rifabutin.
- Filgrastim (G-CSF).
- Itraconazole.
- HIV vaccines.
- Patients must have:
- AIDS.
- CMV retinitis, with severity as specified in the Disease Status field.
- Life expectancy of at least 3 months.
- Consent of parent or guardian if less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known clinically significant allergy to probenecid.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Other active medical problems sufficient to hinder study compliance.
- Concurrent Medication:
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- Excluded:
- Amphotericin B.
- Aminoglycoside antibiotics.
- Vidarabine.
- Intravenous pentamidine.
- CMV hyperimmune immunoglobulin.
- Other nephrotoxic or potentially nephrotoxic agents.
- Other investigational agents with anti-CMV activity.
- Ganciclovir.
- Intravenous or oral acyclovir (except following development of herpetic lesion).
- Foscarnet.
- Diuretics.
- Prior Medication:
- Excluded within 2 days prior to study entry:
- Ganciclovir or foscarnet.
- Excluded within one week prior to study entry:
- Amphotericin B.
- Aminoglycoside antibiotics.
- Vidarabine.
- Intravenous pentamidine.
- CMV hyperimmune immunoglobulin.
- Other nephrotoxic agents.
- Other investigational agents with anti-CMV activity.
- Excluded at any time:
- Prior systemic or intravitreal HPMPC.
- Drug or alcohol abuse that is considered sufficient to hinder study compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Besselaar Associates
Princeton, New Jersey, 085406681
About this study
To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.
Read the detailed description
Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Cidofovir, Probenecid
- Keywords
- Retinitis, Probenecid, Drug Therapy, Combination, 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)
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 Gilead SciencesThe 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
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002142
- Sponsor's protocol ID
- 216B
- Other IDs
- GS-93-107
- Status last verified
- Oct 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Stagg RJ, et al. The Vistide (cidofovir injection) treatment IND for relapsing CMV retinitis (CMV-R). 4th Conf Retro and Opportun Infect. 1997 Jan 22-26;:120 (abstract no 306)
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
- An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS
- ClinicalTrials.gov ID
- NCT00002142
- Acronym / sponsor ID
- 216B
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Probenecid, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Gilead SciencesIndustry (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 evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.
Detailed description
Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Antiretroviral agents.
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
- Fluconazole.
Key exclusion criteria (32 listed)
- Known clinically significant allergy to probenecid.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Other active medical problems sufficient to hinder study compliance.
- Amphotericin B.
- Aminoglycoside antibiotics.
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 24 Jun 2005.
- BackgroundStagg RJ, et al. The Vistide (cidofovir injection) treatment IND for relapsing CMV retinitis (CMV-R). 4th Conf Retro and Opportun Infect. 1997 Jan 22-26;:120 (abstract no 306)
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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.
1 site 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 Gilead Sciences 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 16 inclusion and 32 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?
On the ClinicalTrials.gov record for NCT00002142, 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 24 Jun 2005.