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

September 13, 2005
July 16, 2007
October 2003
Not Provided
To determine the antiviral activity of the combination of 3 monoclonal antibody infusions as an adjunct to HAART
Same as current
Complete list of historical versions of study NCT00219986 on ClinicalTrials.gov Archive Site
To determine the safety of the combination of 3 monoclonal antibody infusions as an adjunct to HAART
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Potent HAART during acute or early HIV-1 infection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2005
Not Provided

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.

-

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219986
MMA 520
Not Provided
Not Provided
Rockefeller University
Not Provided
Principal Investigator: Martin Markowitz, MD Rockefeller University
Principal Investigator: Saurabh Mehandru, MD Rockefeller University Hosp;ital
Principal Investigator: Anita Shet, MD Rockefeller University
Rockefeller University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP