Status:

TERMINATED

Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose interleukin-2 (IL...

Detailed Description

In an HIV-infected person, there is an ongoing struggle between HIV replication and host immune control. In the past decade most therapeutic strategies have targeted the virus. This approach has been ...

Eligibility Criteria

Inclusion Criteria

Patients must have:

  • Serologically confirmed HIV-1 infection.
  • CD4 count >= 400/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

  • Symptoms of HIV-1 disease, except lymphadenopathy.
  • Symptoms of cardiac disease.
  • Evidence of clinical pulmonary disease.
  • Significant medical disease.

Patients with any of the following prior conditions are excluded:

  • History of symptoms of HIV-1 disease, except lymphadenopathy.
  • Participation in another experimental AIDS treatment clinical trial within 4 weeks into entry.
  • History of significant psychiatric disease.
  • History of pancreatitis, history of neuropathy or neurotoxic drug therapy.
  • History of serious allergies requiring either systemic steroid therapy or prior hospitalization.
  • History of significant arrhythmia, infarction or heart failure. Immunomodulatory therapy such as steroids or cyclosporine, systemic chemotherapy or alpha-interferon.

Prior Medication: Exclusion:

  • Past treatment with any protease inhibitor.
  • History of neurotoxic drug therapy.

Risk Behavior: Excluded

  • Patients with current substance abuse.
  • Excessive alcohol intake.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

April 1 2003

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT00000875

End Date

April 1 2003

Last Update

December 14 2016

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The Ctr For Blood Research Inc

Boston, Massachusetts, United States, 02115

Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection | DecenTrialz