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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00002151
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Prior antiretroviral agents for up to 6 months per agent.
Patients must have:
* HIV infection.
* Asymptomatic or mildly symptomatic.
* CD4 count 301 - 500 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
Unable or unwilling to comply with study procedures.
Concurrent Medication:
Excluded:
* Chemoprophylactic therapy for mycobacterial infection.
* Any nonstudy prescription medications without approval of investigator.
Patients with the following prior conditions are excluded:
* History of grade 3 or 4 toxicity to \<= 600 mg/day AZT.
* History of intolerance to lactose.
* Chronic diarrhea within 6 months prior to study entry.
* Unexplained intermittent or chronic fever, defined as temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry.
Prior Medication:
Excluded:
* Antiretroviral therapy within 2 weeks prior to study entry.
* Prior HIV vaccines.
* Biological response modifiers within 30 days prior to study entry.
* Prior foscarnet.
* Any investigational drug with a washout \< 5 half-lives prior to study entry.
* Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.
Recent history of alcohol and/or drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002151
Study Brief:
Protocol Section:
NCT00002151