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Home > "A" Clinical Trials Conditions > A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients with AIDS  A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients with AIDS
A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients with AIDS
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To determine the safety and efficacy of zidovudine (AZT) treatment combined with syngeneic or HLA identical allogeneic lymphocyte transfer in the presence of interleukin 2 (IL-2) as a treatment for AIDS. Patients with documented HIV viremia will be evaluated. Effects on virus replication, immune function, and clinical condition will be monitored with periodic virus cultures, estimates of lymphocyte type and numbers, cell surface markers, in vitro lymphocyte responses and frequent clinical evaluations.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Co-existing Condition: Patients with the following are excluded: Lymphoma. Active central nervous system (CNS) infection by bacteria, varicella zoster virus, herpes simplex virus, or Cryptococcus neoformans. Any prior CNS infection due to Toxoplasma gondii. Any active life-threatening infection including Pneumocystis carinii pneumonia (PCP) (if prior PCP then pre-PCP arterial PO2 must be above 80), disseminated cryptococcosis (if there was a prior cryptococcosis infection the patient must have had a negative blood and cerebrospinal fluid (CSF) culture taken more than 6 weeks after the last antifungal therapy). Any prior mycobacterium avium-intracellulare isolation. Patients with the following conditions are excluded: Lymphoma. Active central nervous system (CNS) infection by bacteria, varicella zoster virus, herpes simplex virus, or Cryptococcus neoformans. Any prior CNS infection due to Toxoplasma gondii. Any active life-threatening infection including Pneumocystis carinii pneumonia (PCP) (if prior PCP then pre-PCP arterial PO2 must be above 80), disseminated cryptococcosis (if there was a prior cryptococcosis infection the patient must have had a negative blood and cerebrospinal fluid (CSF) culture taken more than 6 weeks after the last antifungal therapy). Any prior mycobacterium avium-intracellulare isolation. Patients accepted for allogenic cell transfer must meet the CDC criteria for AIDS. Those patients who meet the criteria only because of Kaposi's sarcoma must also have a history of generalized lymphadenopathy (CDC category III), neurologic disease (CDC category IV-B), or constitutional disease (CDC category IV-A). Patients may be accepted for syngeneic cell transfer even if they have not met the CDC AIDS criteria, provided they have had constitutional disease (CDC category IV-A) or a specified non-AIDS defining secondary infection (CDC category IV-C2). Patients must have a positive blood culture for the AIDS virus before the beginning of therapy. Patients must be skin test negative for PPD. Patients must have a life expectancy of at least 6 months and a Karnofsky status of 60 or above. Patients must sign an informed consent agreement. From eligible patients precedence will be given to those with identical twin donors, then to Minnesota residents. The first patient must have an identical twin donor. Among eligible Minnesota patients without identical twin donors, the order of enrollment will be determined by overall good health, the presence of Kaposi's sarcoma (which permits monitoring of response by measuring lesions) and/or the presence of cytomegalovirus (CMV) viremia (which permits monitoring of response by remission of CMV viremia).
Total Enrollment:
Location and Contact Information:
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: 014B; 27433-10
Study Start Date:
Record last reviewed: February 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002285
Other Hiv Infections Studies:
1. A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
2. A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination with Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment with GLQ223 or Trichosanthin
3. Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis
4. Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
5. A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients with AIDS
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