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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00001067
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
* TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.
Allowed:
* Atovaquone.
* IV pentamidine.
* TMP / SMX.
* Trimetrexate.
* Trimethoprim-dapsone.
* Clindamycin-primaquine.
* Topical antifungals.
* Clotrimazole.
* Ketoconazole.
* Fluconazole.
* Amphotericin B.
* Itraconazole.
* Rifabutin.
* Isoniazid.
* Pyrazinamide.
* Clofazimine.
* Clarithromycin.
* Azithromycin.
* Ethambutol.
* Amikacin.
* Ciprofloxacin.
* Ofloxacin.
* Pyrimethamine.
* Sulfadiazine.
* Clindamycin.
* Filgrastim ( G-CSF ).
* Up to 1000 mg/day acyclovir.
* Erythropoietin.
* Antibiotics.
* Antipyretics.
* Analgesics.
* Antiemetics.
* Rifampin.
Concurrent Treatment:
Allowed:
* Local radiation therapy.
Patients must have:
* HIV infection.
* CD4 count 300 - 600 cells/mm3.
* NO history of AIDS.
* NO active opportunistic infection.
* NO prior nucleoside therapy.
* Life expectancy at least 2 years.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.
* Malignancy requiring systemic cytotoxic chemotherapy.
* Active grade 2 or worse peripheral neuropathy.
Concurrent Medication:
Excluded:
* Antiretrovirals other than study drugs.
* Systemic cytotoxic chemotherapy.
* Foscarnet.
Patients with the following prior conditions are excluded:
* Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days prior to study entry.
* Unexplained temperature \>= 38.5 C for any 7 days within 30 days prior to study entry.
* Active participation in other experimental therapy within 30 days prior to study entry.
Prior Medication:
Excluded:
* Prior nucleoside antiretrovirals of 1 week or longer duration.
* Any antiretroviral within 90 days prior to study entry.
* Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry.
* Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00001067
Study Brief:
Protocol Section:
NCT00001067