Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000705
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Azidothymidine AZT in HIV-Positive Patients With Hemophilia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial to Evaluate Azidothymidine AZT in the Treatment of HIV Infections in Patients With Hemophilia
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:
The purpose of this study is to see if giving azidothymidine AZT to HIV-positive patients with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune system
HIV infects and inactivates certain blood cells that are part of the bodys immune system The damage to the bodys immune system can result in unusual infections andor unusual forms of cancer A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients
HIV infects and inactivates certain blood cells that are part of the bodys immune system The damage to the bodys immune system can result in unusual infections andor unusual forms of cancer A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients
Detailed Description:
There is a clear risk for development of AIDS in hemophilic patients AZT administration has been shown to inhibit HIV replication in vitro Patients taking AZT have experienced fewer opportunistic infections and improvements in measures of immunity The most common laboratory abnormalities observed with AZT are hematologic However the clinical and laboratory toxicity of AZT remains poorly understood in hemophiliacs Hepatitis and liver dysfunction are more common in this population compared to other groups at risk for HIV infection Because AZT is largely metabolized in the liver drug pharmacokinetics needs to be evaluated in this patient population
Both hemophiliacs and non-hemophiliacs take AZT for a period of 12 weeks The first dose is administered intravenously AZT is then given orally every 4 hours while awake 5 doses per day Patients are evaluated by physical examinations and laboratory assessments These include HIV culture of blood and leukocyte counts lymphocyte counts and lymphocyte subsets measured at study entry and every 4 weeks thereafter Patients are hospitalized for pharmacokinetic studies at study entry and at Weeks 6 and 12 Each of these studies involves both intravenous and oral administration within 48 hours of one another Blood is sampled at 0 05 1 2 3 4 6 8 10 and 12 hours after each administration and urine is collected every 2 hours for 12 hours
Both hemophiliacs and non-hemophiliacs take AZT for a period of 12 weeks The first dose is administered intravenously AZT is then given orally every 4 hours while awake 5 doses per day Patients are evaluated by physical examinations and laboratory assessments These include HIV culture of blood and leukocyte counts lymphocyte counts and lymphocyte subsets measured at study entry and every 4 weeks thereafter Patients are hospitalized for pharmacokinetic studies at study entry and at Weeks 6 and 12 Each of these studies involves both intravenous and oral administration within 48 hours of one another Blood is sampled at 0 05 1 2 3 4 6 8 10 and 12 hours after each administration and urine is collected every 2 hours for 12 hours
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 |
|---|---|---|---|
| 10993 | REGISTRY | DAIDS ES Registry Number | None |