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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00002269
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV-1 seropositivity.
* Absolute number of T4 cells 100-300 cells/mm3.
* Given informed consent.
* Zidovudine (AZT) therapy for 6 months prior to study entry.
* At least one of the listed HIV-related clinical symptoms or opportunistic infections:
* weight loss \> 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis \> 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Evidence of AIDS.
* Intercurrent acute medical disorder.
Concurrent Medication:
Excluded:
* Chemotherapy for Kaposi's sarcoma (KS).
* Aspirin.
* Non-steroidal anti-inflammatory drugs.
Patients with the following are excluded:
* Inability to return for treatment and evaluation for 12 months.
* Intercurrent acute medical disorder.
* Evidence of AIDS.
* Receiving chemotherapy for Kaposi's sarcoma (KS).
* Unwilling or unable to give informed consent.
Required:
* Zidovudine (AZT).
Required at least 6 months prior to study entry:
* Zidovudine (AZT).
Active drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002269
Study Brief:
Protocol Section:
NCT00002269