Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063804
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2003-07-07
Brief Title:
Safety of AMD070 When Administered Alone or Boosted With Low-Dose Ritonavir in HIV Uninfected Men
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase 1 Dose-Rising Study of AMD11070 in HIV-Seronegative Men to Assess the Safety and Pharmacokinetics After Single or Multiple Doses
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:
Most currently approved anti-HIV drugs work by stopping the replication of HIV after it has entered cells AMD070 also known as AMD11070 is designed to block HIV from entering cells and may be effective in treating patients who have developed resistance to or are unable to take other anti-HIV drugs This study will evaluate the safety of different doses of AMD070 along with AMD070 boosted with ritonavir RTV in HIV uninfected men
Detailed Description:
Current therapy for HIV infection primarily uses drugs that inhibit HIV replication via inhibition of viral protease and reverse transcriptase Many patients either do not tolerate these medications well or develop virologic failure due to incomplete viral suppression and development of antiviral resistance New drugs target HIV entry into the cell AMD070 binds to the chemokine receptor CXCR4 inhibiting membrane fusion and viral entry Animal studies have shown AMD070 to be generally safe and well tolerated The dose-escalation and drug-drug interaction study will evaluate the safety tolerability and pharmacokinetics of single multiple and RTV-boosted doses of AMD070 in healthy HIV uninfected male volunteers
Participants in this study will be assigned to a single- or multiple-dose AMD070 group Group 1 a single-dose AMD070 group Group 2 or an RTV-boosted multiple-dose AMD070 group Group 3 Some participants in Group 1 will be given AMD070 once on an empty stomach with no food or drink except for water for 2 hours before and 1 hour after receiving the drug Up to 4 different doses will be tested in subgroups of Group 1 participants Some participants in Group 1 will be given AMD070 7 times 12 hours apart after eating a standardized breakfast 30 minutes before receiving the drug 3 different doses will be tested in this group Participants in Group 2 will be given a single dose of AMD070 after eating a standardized meal Participants in Group 3 will be given a morning dose of AMD070 on Days 1 3 and 17 after eating a standardized breakfast 30 minutes before receiving the drug and a morning and evening dose of RTV on Days 3 through 18 Group 3 participants may also be asked to enroll in an additional study group that will receive a single dose of AMD070 on Days 1 and 3 while fasting
All participants will be observed as hospital inpatients Group 1 and 2 participants will stay in the hospital for 24 hours Group 3 participants will stay in the hospital for 4 days All participants will have blood and urine collection throughout their hospital stay Group 3 participants selected to join in the additional study group will have blood and urine samples collected throughout the 5-day study These participants will be discharged from the hospital on Day 5 and have a follow-up visit around Day 35 All study participants will also undergo an ophthalmologic evaluation and questionnaire sometime after receiving AMD070
Participants in this study will be assigned to a single- or multiple-dose AMD070 group Group 1 a single-dose AMD070 group Group 2 or an RTV-boosted multiple-dose AMD070 group Group 3 Some participants in Group 1 will be given AMD070 once on an empty stomach with no food or drink except for water for 2 hours before and 1 hour after receiving the drug Up to 4 different doses will be tested in subgroups of Group 1 participants Some participants in Group 1 will be given AMD070 7 times 12 hours apart after eating a standardized breakfast 30 minutes before receiving the drug 3 different doses will be tested in this group Participants in Group 2 will be given a single dose of AMD070 after eating a standardized meal Participants in Group 3 will be given a morning dose of AMD070 on Days 1 3 and 17 after eating a standardized breakfast 30 minutes before receiving the drug and a morning and evening dose of RTV on Days 3 through 18 Group 3 participants may also be asked to enroll in an additional study group that will receive a single dose of AMD070 on Days 1 and 3 while fasting
All participants will be observed as hospital inpatients Group 1 and 2 participants will stay in the hospital for 24 hours Group 3 participants will stay in the hospital for 4 days All participants will have blood and urine collection throughout their hospital stay Group 3 participants selected to join in the additional study group will have blood and urine samples collected throughout the 5-day study These participants will be discharged from the hospital on Day 5 and have a follow-up visit around Day 35 All study participants will also undergo an ophthalmologic evaluation and questionnaire sometime after receiving AMD070
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5191 | Registry Identifier | DAIDS ES | None |
| 10012 | REGISTRY | None | None |