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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00002435
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).
* Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to \< 200 cells/mm3.
* Other marketed drugs as required.
Patients must have:
* HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
* No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.
* Mean CD4 of 200-500 cells/mm3.
* HIV-1 positive PCR RNA.
* Ability to self-administer study drug by IM injection.
* Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at \>= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Malignancy.
* Hematuria.
* Proteinuria \> 1+.
Concurrent Medication:
Excluded:
* Non-antiretroviral agents with known or suspected activity against HIV.
* Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.
Patients with the following prior conditions are excluded:
Myositis within the past 6 months.
Prior Medication:
Excluded:
* Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.
* Prior antiretroviral therapy (AZT-naive patients only).
Prior Treatment:
Excluded within 6 weeks prior to study entry:
* Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002435
Study Brief:
Protocol Section:
NCT00002435