Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT00000659
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00000659
Study Brief:
Protocol Section:
NCT00000659