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

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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Potent HAART during acute or early HIV-1 infection

• Study Type: Interventional
• Enrollment: 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Rockefeller University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the antiviral activity of the combination of 3 monoclonal antibody infusions as an adjunct to HAART

Secondary Outcome Measures

Outcome Measure
To determine the safety of the combination of 3 monoclonal antibody infusions as an adjunct to HAART

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion: September 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): July 18, 2007
• Last Update Submitted That Met QC Criteria: July 16, 2007
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: HIV; Treatment Experienced
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: MMA 520