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To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.
Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI-1012 | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Treatment with anticancer agents within 4 weeks prior to study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ViRx Inc | Palm Springs | California | 92262 | United States | ||
| ViRx Inc |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| San Francisco |
| California |
| 94109 |
| United States |
| Central Florida Research Initiative | Maitland | Florida | 32751 | United States |
| Natl Institutes of Health | Bethesda | Maryland | 20892 | United States |
| Univ of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Univ of Utah Med School / Clinical Trials Ctr | Salt Lake City | Utah | 84108 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |