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NCT00114699 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
A Phase 1 study, sponsored by Human Genome Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00114699 is a Phase 1 study that has completed, run by Human Genome Sciences. The registered enrollment target is 40 participants.
The verdict
NCT00114699, a Phase 1 study, has completed, sponsored by Human Genome Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of 60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United States. Subjects in each cohort will be followed for 56 days after study agent administration. The safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1 RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the study period, the subject should be offered standard-of-care per HIV treatment guidelines that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004 pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period. Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and Day 56.
Interventions
- DRUG CCR5mAb004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00114699
The ClinicalTrials.gov registry entry for NCT00114699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CCR5mAb004 is the first listed.
NCT00114699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00114699 about?
NCT00114699 is a clinical study titled "Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy". This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of four dose levels of CCR5mAb004 ...
What is the current status of trial NCT00114699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-04. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00114699?
The interventions under investigation include: CCR5mAb004 (DRUG).
Who is sponsoring clinical trial NCT00114699?
This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
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