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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00001104
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed with caution for Study A:
* Hepatotoxic drugs.
Patients in Study A must have:
* Hemophilia with no symptoms for AIDS. Most patients will have well-established factor 8 or 9 deficiency. However, patients with other coagulation diseases, such as factor 5 deficiency, and von Willebrand disease, will also be acceptable for the study.
Wives in Study B are included even if they are known to be seropositive or are not sexually active at the time the study starts.
Prior Medication:
Allowed for Study A:
* Patients who were on the Phase I ZDV study, ACTG 017, or are on ACTG 062 may enter after waiting 3 weeks.
Exclusion Criteria
Co-existing Condition:
Patients in Study A with the following symptoms or conditions are excluded:
* AIDS-defining illness.
* Severe ARC.
* Severe or prolonged toxicity.
Concurrent Medication:
Excluded for Study A:
* Isoniazid or rifampin.
* Treatment for Pneumocystis carinii pneumonia (PCP), oral candidiasis, and localized cutaneous herpes simplex or zoster infections.
* Probenecid.
* Aspirin on a regular basis, or for more than 72 hours without contacting the investigator.
* Drugs causing neutropenia or significant risk of nephrotoxicity.
Patients in Study A with the following prior conditions are excluded:
* AIDS-defining opportunistic infection or malignancy.
* Unexplained temperature greater than 38 C for more than 5 consecutive days or more than 10 days in any 30-day period in the 2 years prior to entry.
* Unexplained diarrhea defined as three or more liquid stools per day, persisting more than 7 days within 2 years prior to entry.
* Unintentional weight loss of greater than 10 lbs. or more than 10 percent of usual body weight within 2 years prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Oral candidiasis unrelated to the use of antibiotic therapy for more than 2 weeks within 2 years prior to entry or within the past 3 months.
* Herpes zoster within 2 years prior to entry into the study.
Prior Medication:
Excluded for Study A:
* Antiretroviral agents, including ZDV, ribavirin, HPA-23, rifampin, AL721 within 8 weeks of study entry.
* Significant course of immunomodulating agents such as steroids (greater than 1 week), isoprinosine, thymic factors within 3 months of study entry.
* Any other experimental therapy within 3 months of study entry.
Discouraged but not forbidden for Study B:
* Sexual contact with infected husband.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00001104
Study Brief:
Protocol Section:
NCT00001104