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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Sex Behavior, T-Lymphocytes, HIV Antibodies, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Hemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • Univ of California / San Diego Treatment Ctr
  • Stanford Univ School of Medicine
  • Northwestern Univ Med School
  • Cook County Hosp
  • Chicago Children's Memorial Hosp
  • Indiana Univ Hosp
  • Tulane Univ School of Medicine
  • Children's Hosp of Boston
  • Univ of Massachusetts Med Ctr
  • Univ of Minnesota
  • Cornell Univ Med Ctr
  • Mount Sinai Med Ctr
  • Univ of Rochester Medical Center
  • Univ of North Carolina
  • Holmes Hosp / Univ of Cincinnati Med Ctr
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Ohio State Univ Hosp Clinic
  • Milton S Hershey Med Ctr
  • Hemophilia Ctr of Western PA / Univ of Pittsburgh
  • Univ of Pittsburgh Med School
  • Baylor College of Medicine
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001104
Brief Title
A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
Official Title
A Placebo Controlled Trial To Evaluate Zidovudine (ZDV) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Hemophilic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed 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 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. Study A: Patients selected for the study are randomly assigned to placebo (inactive medication) or ZDV taken every 4 hours while the patient is awake for a total of 5 doses per day. The patient's immune function and clinical condition are monitored with periodic virus cultures, p24 antigen assays, estimates of lymphocyte type and numbers, cell surface markers, and frequent clinical evaluations to see if these are markers of drug efficacy. Patients continue on their regimen until the final analysis of the data, which could occur up to 3 years after the last patient is entered into the study. Amendment: Based on data from ACTG 019 this protocol has been closed to further accrual. All patients entered in this study will be unblinded as to treatment received. Patients will be informed of results of ACTG 019 and be requested to sign a modified statement of consent approved by the local Institutional Review Board. All patients currently receiving study therapy will be offered open-label ZDV. Patients temporarily discontinued from study therapy at this time will be offered open-label ZDV when toxicity resolves (less than or equal to Grade 2 hemoglobin or neutrophil toxicity, less than or equal to Grade 1 all other toxicities). Patients who have been permanently discontinued from study therapy will not be eligible for open-label ZDV through this protocol. Modification of dose is recommended, however, patients who elect to continue current dose of ZDV after being informed of results of ACTG 019 will be allowed to do so. All patients enrolled in this study will continue to be followed until termination of this study. Above amendment added 11/01/89. Study B: The wife or other female sexual partner is interviewed once at the beginning of the study and again when Study A is completed. The interview takes about 10 minutes and includes questions about the couple's sexual activity to help define the risk of becoming infected with HIV. In addition, blood is drawn to test for antibodies to HIV. The questionnaire and blood sample will be repeated at the time the patient is switched from blinded study therapy to open-label ZDV. (AMENDED 11/01/89) The results of the blood test are given to the person being tested. Information about the transmission of HIV and counseling are provided. It is recommended that the wife abstain from sexual contact with her husband, but if she does not, the use of condoms or condoms plus a spermicide is recommended. The decision about the type of precautions to take does not influence the opportunity to participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Sex Behavior, T-Lymphocytes, HIV Antibodies, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Hemophilia A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
538 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas C. Merigan
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
Stanford Univ School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Univ of Massachusetts Med Ctr
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Holmes Hosp / Univ of Cincinnati Med Ctr
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Hemophilia Ctr of Western PA / Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Univ of Pittsburgh Med School
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Price W, Merigan T, Peterman T. Condom usage reported by female sexual partners of asymptomatic HIV seropositive hemophilic men. Int Conf AIDS. 1989 Jun 4-9;5:420 (abstract no ThBP30)
Results Reference
background

Learn more about this trial

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

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