Status:

COMPLETED

Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenop...

Detailed Description

AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in ...

Eligibility Criteria

Inclusion Criteria

  • Detectable HIV nucleic acid in patient peripheral blood mononuclear leukocytes (PBML's) by the gene amplification technique. A positive antibody to HIV confirmed by any federally licensed ELISA test kit.

Concurrent Medication:

Allowed:

  • Medications without which there might be significant risk, such as seizures, loss of diabetic control or respiratory embarrassment.
  • Necessary topical agents including topical acyclovir.
  • Diuretics for significant fluid retention only.

Concurrent Treatment:

Allowed:

  • Blood transfusions for anemia if hematocrit falls below 25 percent.

Exclusion Criteria

  • Active drug or alcohol abuse.

Co-existing Condition:

Patients with the following will be excluded:

  • Grade 1 impairment on two or more items in the ACTG Micro Neuro AIDS assessment.
  • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Major organ allograft.
  • Significant cardiac disease or central nervous system lesions.
  • Patients with hemophilia should be evaluated and treated under the hemophilia protocol.

Concurrent Medication:

Excluded:

  • Inderal or vasoactive hypertensive medication.
  • Non-essential medications including pain medications.

Excluded are:

  • Patients with an opportunistic infection or malignancy fulfilling the definition of AIDS.

Patients with AIDS related complex, defined as:

  • 1. Weight loss in excess of 15 lbs. or 10 percent of body weight noted in a 2-year period prior to entry into the study. 2. Temperature greater than 38.5 degrees C with or without night sweats, persisting for more than 14 consecutive days or more than 15 days in a 30-day interval during a 2-year period prior to entry into the study. 3. Diarrhea defined as = or > 3 liquid stools per day, persisting for more than 30 days during a 2-year period prior to entry into the study without a definable cause. 4. Herpes zoster during the past 2 years. 5. Oral candidiasis or biopsy-proven hairy leukoplakia during the last 2 years. 6. Active substance abuse.

Prior Medication:

Excluded:

  • Zidovudine (AZT).
  • Excluded within 30 days of study entry:
  • Antiretroviral agents.
  • Biologic response modifiers.
  • Corticosteroids.
  • Excluded within 60 days of study entry:
  • Ribavirin.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

April 1 1990

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00000728

End Date

April 1 1990

Last Update

November 3 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Stanford Univ School of Medicine

Stanford, California, United States, 94305

Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy | DecenTrialz