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A Study of CI-1012 in HIV-Infected Patients



A Study of CI-1012 in HIV-Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Parke-Davis ,
Synopsis: The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.
Details: Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.
Eligibility:
Study Type:  Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Serologic evidence of infection with HIV-1. - CD4+ cell count >= 200 cells/mm3. - HIV-1 RNA >= 10,000 copies/ml. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Viral, fungal, or bacterial infection requiring therapy other than topical medications. Concurrent Medication: Excluded: - Prophylactic systematic antibacterial, antifungal or antiviral agents. - Antiretroviral therapy. NOTE: - Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication. Prior Medication: Excluded: - Experimental therapy for >= 4 weeks prior to initiation of study medication. - Antiretroviral treatment for 3 weeks prior to initiation of study medication. - Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.
Total Enrollment: 32

Location and Contact Information:

Central Florida Research Initiative
Maitland,  Florida,  32751
United States
 

Natl Institutes of Health
Bethesda,  Maryland,  20892
United States
 

ViRx Inc
Palm Springs,  California,  92262
United States
 

ViRx Inc
San Francisco,  California,  94109
United States
 


Additional Information:
Study ID Numbers:  278A;  1012-005
Study Start Date: 
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002196

Other Hiv Infections Studies:
1. The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients with AIDS Who Have Taken Zidovudine

2. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children

3. Vitamin B Therapy for Hyperlactatemia

4. A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.

5. Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success with Nelfinavir

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