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Not Recruiting
Trial ID: NCT00001104
A Placebo Controlled Trial To Evaluate Zidovudine (ZDV) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Hemophilic Patients
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.
drug: Zidovudine
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305