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

Stopped early · Phase 2

Conditions studied: HIV Infections

In brief

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 pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients with AIDS and advanced ARC. 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 been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.

Key facts

Study ID

NCT00000659

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

80

Last updated by the study team

2011-03-14

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.