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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT00002250
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).
* Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.
Patients must have the following:
* HIV seropositive (asymptomatic, AIDS-related complex, or AIDS).
* HIV-associated immune thrombocytopenic purpura.
* The ability to sign a written informed consent form, which must be obtained prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* Patients currently on zidovudine are not excluded. However, the zidovudine dose level must remain constant for 4 weeks prior to entry and for the 12 weeks of treatment, except if zidovudine related toxicity is observed.
* A life expectancy of at least 3 months.
Prior Medication:
Allowed:
* Dapsone at a constant dose for more than 2 weeks prior to study entry.
* Zidovudine at a constant dose for 4 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
* Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
* Malignancies other than Kaposi's sarcoma.
* Tumor-associated edema.
* Visceral Kaposi's sarcoma.
* Significant neurologic, cardiac, or liver disease.
Concurrent Medication:
Excluded:
* Ganciclovir (DHPG). Pyrimethamine. Clindamycin. Sulfadiazine. Folinic acid. Prednisone. Intravenous gamma globulin. Intravenous acyclovir. Interferon. Systemic corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). Known immunomodulatory agents. Dideoxycytosine. Dideoxyinosine. Nucleoside analogs (with the exception of zidovudine or topical acyclovir). Any experimental therapy.
Patients with the following are excluded:
* Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
* Malignancies other than Kaposi's sarcoma.
* Kaposi's sarcoma requiring therapy.
* Tumor-associated edema.
* Visceral Kaposi's sarcoma.
* Significant neurologic, cardiac, or liver disease.
* Conditions requiring excluded concomitant medications.
* Herpes virus infection requiring intravenous acyclovir.
Prior Medication:
Excluded for a minimum of 4 weeks prior to study entry:
* Chemotherapy.
* Immunomodulatory agents.
* Any experimental therapy.
Prior Treatment:
Excluded for a minimum of 4 weeks prior to study entry:
* Radiation therapy.
* Any experimental therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002250
Study Brief:
Protocol Section:
NCT00002250