Status:

TERMINATED

A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Biogen

Conditions:

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE2

Brief Summary

Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharma...

Detailed Description

AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furt...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Nystatin or clotrimazole for suppression of oral thrush.
  • Aerosolized pentamidine as chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Trimethoprim / sulfamethoxazole (TMP / SMX) for patients who are clinically and hematologically stable on TMP / SMX PCP prophylaxis.

Patients must have the following:

  • Diagnosis of AIDS or advanced AIDS related complex (ARC).
  • CD4 cell count < 300 cells/mm3.
  • Ability to understand and sign the consent form.

Risk Behavior:

Allowed:

  • History of drug abuse with current abstinence or enrollment in a methadone treatment program.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malignancies other than Kaposi's sarcoma.
  • AIDS dementia which, in the opinion of the investigator, precludes patients from giving fully informed consent or from complying fully with the requirements of this protocol.
  • Active infection with an opportunistic pathogen requiring ongoing therapy.
  • Preexisting antibodies to rCD4.

Concurrent Medication:

Excluded:

  • Investigational drugs.
  • Antiretroviral agents such as dextran sulfate or AL721.
  • Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

  • Radiation therapy.

Patients with the following are excluded:

  • Malignancies other than Kaposi's sarcoma.
  • AIDS dementia which, in the opinion of the investigator, precludes patients from giving fully informed consent or from complying fully with the requirements of this protocol.
  • Active infection with an opportunistic pathogen requiring ongoing therapy.
  • Preexisting antibodies to rCD4.

Prior Medication:

Excluded:

  • Zidovudine (AZT) for longer than 30 days or prior treatment with AZT for < 30 days if discontinued for toxicity due to AZT.
  • Excluded within 30 days of study entry:
  • Immunomodulators.
  • Previous participation in any group of another part of this study. For example, patients treated in Part 1A of this study may not reenter the study to be treated in Part 2.
  • Chemotherapy.

Prior Treatment:

Excluded within 30 days of study entry:

  • Radiation therapy.

Active use of illicit drugs or abuse of alcohol at time of protocol entry.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT00000659

Last Update

March 14 2011

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Tulane Univ School of Medicine

New Orleans, Louisiana, United States, 70112

2

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016