A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

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.

Completed

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ViRx Inc, Palm Springs, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have:

Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
CD4 T cell count less than or equal to 200 mm3.
HIV-1 RNA greater than or equal to 5,000 copies/mL.

Exclusion criteria

Prior Medication:

Excluded:

Anti-HIV treatment within 8 weeks prior to entry.
Systemic steroids within 4 weeks prior to entry.

Prior Treatment:

Excluded:

Treatment with anticancer agents within 4 weeks prior to study.

Treatment and study plan

CI-1012

Drug

Sponsors and collaborators

Lead sponsor

Parke-Davis

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed