Completed

CI-1012 Dosing for Late-Stage HIV+ Patients

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What is being tested

CI-1012

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorParke-Davis
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002218
Principal SponsorParke-Davis
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

3 inclusion criteria required to participate
CD4 T cell count less than or equal to 200 mm3
HIV-1 RNA greater than or equal to 5,000 copies/mL
Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot)
3 exclusion criteria prevent from participating
Anti-HIV treatment within 8 weeks prior to entry
Systemic steroids within 4 weeks prior to entry
Treatment with anticancer agents within 4 weeks prior to study

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

ViRx Inc

Palm Springs, United StatesOpen ViRx Inc in Google Maps

ViRx Inc

San Francisco, United States

Central Florida Research Initiative

Maitland, United States

Natl Institutes of Health

Bethesda, United States
Completed6 Study Centers