Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000991
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection
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:
To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine AZT in persons with HIV infection and T4 cell count less than 200 cellsmm3 All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study ACTG 981 of systemic antifungal therapy fluconazole versus local therapy Clotrimazole for the prevention of serious fungal disease
Persons with HIV disease who are receiving AZT are at risk for PCP toxoplasmosis bacterial pneumonia and other serious infections It is therefore important to find drugs that can be given along with AZT to control these infections Aerosolized pentamidine PEN has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP Both sulfamethoxazoletrimethoprim SMXTMP and dapsone probably also provide effective preventive treatment against PCP and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis
Persons with HIV disease who are receiving AZT are at risk for PCP toxoplasmosis bacterial pneumonia and other serious infections It is therefore important to find drugs that can be given along with AZT to control these infections Aerosolized pentamidine PEN has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP Both sulfamethoxazoletrimethoprim SMXTMP and dapsone probably also provide effective preventive treatment against PCP and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis
Detailed Description:
Persons with HIV disease who are receiving AZT are at risk for PCP toxoplasmosis bacterial pneumonia and other serious infections It is therefore important to find drugs that can be given along with AZT to control these infections Aerosolized pentamidine PEN has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP Both sulfamethoxazoletrimethoprim SMXTMP and dapsone probably also provide effective preventive treatment against PCP and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis
All patients receive AZT In addition they are placed in one of three groups to receive either SMXTMP dapsone or PEN Stratification criteria are
Received first AZT equal to or less than 6 weeks prior to study entry Received first AZT more than 6 weeks prior to study entry Potential to participate in ACTG 981 ACTG center in which the patient is enrolled
All patients receive AZT In addition they are placed in one of three groups to receive either SMXTMP dapsone or PEN Stratification criteria are
Received first AZT equal to or less than 6 weeks prior to study entry Received first AZT more than 6 weeks prior to study entry Potential to participate in ACTG 981 ACTG center in which the patient is enrolled
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 |
|---|---|---|---|
| 11056 | REGISTRY | DAIDS ES Registry Number | None |