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| ID | Type | Description | Link |
|---|---|---|---|
| GS-93-106 |
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To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.
Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cidofovir | Drug | |||
| Probenecid | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Excluded within 1 week prior to study entry:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | United States | ||
| UCI Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lalezari J, et al. A phase II/III randomized study of immediate versus deferred intravenous (IV) cidofovir (CDV, HPMPC) for the treatment of peripheral CMV retinitis (CMV-R) in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:170 |
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| Orange |
| California |
| 92668 |
| United States |
| Mount Zion Med Ctr | San Francisco | California | 94115 | United States |
| Beth Israel Hosp | Boston | Massachusetts | 02215 | United States |
| Besselaar Associates | Princeton | New Jersey | 085406681 | United States |
| Univ of Rochester Med Ctr | Rochester | New York | 14607 | United States |
| Univ of North Carolina Hosps | Chapel Hill | North Carolina | 27599 | United States |
| Audie L Murphy Veterans Administration Hosp | San Antonio | Texas | 78284 | United States |
| Charing Cross and Westminster Med School | London Southwest 10 | United Kingdom |
| ID | Term |
|---|---|
| D017726 | Cytomegalovirus Retinitis |
| D015658 | HIV Infections |
| D012173 | Retinitis |
| D003586 | Cytomegalovirus Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D000077404 | Cidofovir |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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