Phase I/II, Open-Label Trial of Three Monoclonal Antibodies
NCT ID: NCT00219986
Last Updated: 2007-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2003-10-31
2005-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Potent HAART during acute or early HIV-1 infection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Absolute neutrophil count (ANC) equal to or greter than 750/mm3.
* Hemoglobin equal to or greater than 9.5 g/dL.
* Platelet count equal to or greater than 50,000/mm3.
* Calculated creatinine clearance (CrCl) equal to or greater than 80 mL/min according to the Cockcroft-Gault formula:
Men: (140-age in years) x (wt in kg) = CrCl (mL/min) 72 x (serum creatinine in mg/dL)
Female: (140-age in years) x (wt in kg) x 0.85 = CrCl (mL/min) 72 x (serum creatinine in mg/dL)
* AST (SGOT), ALT (SGPT), and alkaline phosphatase equal to or less than 5 x ULN.
* Total bilirubin equal to or less than 2.5 x ULN.
* Serum Lipase equal to or less than 1.5 x ULN
Negative serum pregnancy test within 14 days. All females of childbearing potential must agree to practice active birth control measures (barrier methods such as condoms, diaphragms, cervical cap, etc. or an intrauterine device such as a coil) to avoid pregnancy while receiving the study drugs and for 30 days after the last dose of the study drugs. Additionally, men enrolled in the study should practice active birth control for the same period of time with their female partners of childbearing potential.
Men and women age \>18 years. Ability and willingness of subject to give written informed consent -
Exclusion Criteria
Pregnancy and breast-feeding.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry.
\-
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rockefeller University
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Markowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Rockefeller University
Saurabh Mehandru, MD
Role: PRINCIPAL_INVESTIGATOR
Rockefeller University Hosp;ital
Anita Shet, MD
Role: PRINCIPAL_INVESTIGATOR
Rockefeller University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rockefeller University Hospital
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MMA 520
Identifier Type: -
Identifier Source: org_study_id