A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia

Completed · Phase 3

Conditions studied: HIV Infections

In brief

Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of ZDV in hemophilic patients will also be studied. Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to his wife or other female sexual partner. To determine the effectiveness of counseling and education on the behaviors of the wives that place them at risk for HIV infection. To determine if antibodies to HIV either appear or disappear from the blood of any of the wives during the study. Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV. Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.

Key facts

Study ID: NCT00001104
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 538
Expected to finish: 1990-02-01
Last updated by the study team: 2021-11-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Los Angeles County - USC Med Ctr — Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr — San Diego, California, United States
Stanford Univ School of Medicine — Stanford, California, United States
Northwestern Univ Med School — Chicago, Illinois, United States
Cook County Hosp — Chicago, Illinois, United States
Chicago Children's Memorial Hosp — Chicago, Illinois, United States
Indiana Univ Hosp — Indianapolis, Indiana, United States
Tulane Univ School of Medicine — New Orleans, Louisiana, United States
Children's Hosp of Boston — Boston, Massachusetts, United States
Univ of Massachusetts Med Ctr — Worcester, Massachusetts, United States
Univ of Minnesota — Minneapolis, Minnesota, United States
Cornell Univ Med Ctr — New York, New York, United States
Mount Sinai Med Ctr — New York, New York, United States
Univ of Rochester Medical Center — Rochester, New York, United States
Univ of North Carolina — Chapel Hill, North Carolina, United States
Holmes Hosp / Univ of Cincinnati Med Ctr — Cincinnati, Ohio, United States
Univ Hosp of Cleveland / Case Western Reserve Univ — Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
Milton S Hershey Med Ctr — Hershey, Pennsylvania, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States
Univ of Pittsburgh Med School — Pittsburgh, Pennsylvania, United States
Baylor College of Medicine — Houston, Texas, United States
Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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