Search / Trial NCT00001104

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of April 16, 2024

Completed

Keywords

Sex Behavior T Lymphocytes Hiv Antibodies Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Hemophilia A

Description

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...

Gender

All

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.

Attachments

readout_NCT00001104_2024-04-16.pdf

4.5 MB

NCT00001104_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Houston, Texas, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

Stanford, California, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Hershey, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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