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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has ...

Gender

ALL

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.