Phase I/II, Open-Label Trial of Three Monoclonal Antibodies

This study has been completed.
Sponsor:
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00219986
First received: September 13, 2005
Last updated: July 16, 2007
Last verified: September 2005
  Purpose

Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed HAART-treated individuals who began therapy during acute and early HIV-1 infection.


Condition Intervention Phase
HIV Infections
Drug: Potent HAART during acute or early HIV-1 infection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Single Site Open Label Trial of the Safety and Antiviral Activity of C2F5, C2G12, and C4E10 Monoclonal Antibody Infusions in Well-Suppressed HAART-Treated Individuals Treated During Acute and Early HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • To determine the antiviral activity of the combination of 3 monoclonal antibody infusions as an adjunct to HAART

Secondary Outcome Measures:
  • To determine the safety of the combination of 3 monoclonal antibody infusions as an adjunct to HAART

Estimated Enrollment: 12
Study Start Date: October 2003
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. Acute or early HIV-1 infection at the time of HAART initiation defined by HIV-1 RNA detectable with a negative serology or a negative detuned ELISA. HAART for at least 15 months and no more than 1 detectable HIV-1 RNA value (above the 50 copy/mL) for at least 6 months prior to screening.

Laboratory values

  • 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:

More than 1 detectable HIV-1 RNA value (>50 copies/mL) within 6 months of screening visit

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219986

Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Martin Markowitz, MD Rockefeller University
Principal Investigator: Saurabh Mehandru, MD Rockefeller University Hosp;ital
Principal Investigator: Anita Shet, MD Rockefeller University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00219986     History of Changes
Other Study ID Numbers: MMA 520
Study First Received: September 13, 2005
Last Updated: July 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockefeller University:
Treatment Experienced
HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014