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A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients With AIDS
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002285
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: A Phase I/II Pilot Trial To Evaluate Zidovudine (AZT) and T Lymphocyte Transfer in the Treatment of Human Immunodeficiency Virus Type-III (HIV) Infection in AIDS Patients

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002285

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

Study ID Numbers: 014B, 27433-10
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002285     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Virus Replication
Pilot Projects
Immune Tolerance
Lymphocytes
Drug Evaluation
Combined Modality Therapy
Acquired Immunodeficiency Syndrome
Transplantation, Homologous
Zidovudine

Study placed in the following topic categories:
Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 02, 2009