Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001104
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Placebo Controlled Trial To Evaluate Zidovudine ZDV in the Treatment of Human Immunodeficiency Virus HIV Infection in Hemophilic Patients
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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 110189
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 couples 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 110189 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
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 patients 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 110189
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 couples 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 110189 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11012 | REGISTRY | DAIDS ES Registry Number | None |