Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000771
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Double-Blind Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cellsmm3
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 determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection To evaluate the safety of oral paromomycin at two different doses To explore whether paromomycin administered over a longer period provides additional benefit
In previous studies patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy
In previous studies patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy
Detailed Description:
In previous studies patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy
Patients are randomized to receive either placebo or paromomycin for 3 weeks After the initial double-blind phase all patients receive open-label paromomycin for 3 weeks Following 6 weeks of therapy patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks while complete responders continue receiving the original dose for an additional 3 weeks Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved Treatment continues for up to 25 weeks total Patients are followed at weeks 1 3 4 6 7 and 9 and then at 2-4 week intervals
Patients are randomized to receive either placebo or paromomycin for 3 weeks After the initial double-blind phase all patients receive open-label paromomycin for 3 weeks Following 6 weeks of therapy patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks while complete responders continue receiving the original dose for an additional 3 weeks Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved Treatment continues for up to 25 weeks total Patients are followed at weeks 1 3 4 6 7 and 9 and then at 2-4 week intervals
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 |
|---|---|---|---|
| 11167 | REGISTRY | DAIDS ES Registry Number | None |