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Home > "A" Clinical Trials Conditions > A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients  A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Parke-Davis ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 40
Location and Contact Information:
ViRx Inc
Palm Springs, California, 92262
United States
ViRx Inc
San Francisco, California, 94109
United States
Univ of Michigan
Ann Arbor, Michigan, 48109
United States
Natl Institutes of Health
Bethesda, Maryland, 20892
United States
Central Florida Research Initiative
Maitland, Florida, 32751
United States
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, 84108
United States
Additional Information:
Study ID Numbers: 278B;
Study Start Date:
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002218
Other Hiv Infections Studies:
1. A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
2. Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
3. A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
4. Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
5. The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Maitland Clinical Trials
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
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