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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002218

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, Dose-Response Relationship, Drug, Anti-HIV Agents

Brief summary

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.

Detailed description

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.

Interventions

DRUGCI-1012

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026