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NCT00000693 · ClinicalTrials.gov registry record · NA
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
A NA study of HIV Infections and Cytomegalovirus Retinitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT00000693 is a NA study of HIV Infections and Cytomegalovirus Retinitis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 25 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00000693, a NA study of HIV Infections and Cytomegalovirus Retinitis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG) alone. CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) count (leukopenia) which is a known side effect of the drug; and 2) the increased risk for leukopenia when DHPG is given together with AZT, the only antiviral drug currently available for the treatment of HIV infection. Therefore, patients cannot take both AZT and DHPG at the same time because the bone marrow toxicity is made much more severe when the drugs are given together. This has resulted in the difficult decision as to whether to forgo potential life-extending therapy with AZT in order to preserve sight. An effective treatment for CMV retinitis is needed that will allow the patient to also take AZT. ACV is presently the drug of choice for severe herpes virus infections. It has been shown to be effective in suppressing severe CMV disease in patients who have received bone marrow transplants.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Acyclovir
Study Locations (2)
Illinois
- Northwestern Univ Med School - Chicago
- Rush Presbyterian - Saint Luke's Med Ctr - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Est. Completion | 1992-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000693
The ClinicalTrials.gov registry entry for NCT00000693 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000693 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT00000693 about?
NCT00000693 is a clinical study titled "Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS". To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG) alone. CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present...
What is the current status of trial NCT00000693?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. Estimated completion is 1992-03.
What conditions does trial NCT00000693 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Retinitis.
What interventions are being tested in trial NCT00000693?
The interventions under investigation include: Zidovudine (DRUG), Acyclovir (DRUG).
Who is sponsoring clinical trial NCT00000693?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000693 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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