Clinical trial NCT00219986: Phase I/II, Open-Label Trial of Three Monoclonal Antibodies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: Treatment Experienced
HIV
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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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Primary outcomes:
measure: To determine the antiviral activity of the combination of 3 monoclonal antibody infusions as an adjunct to HAART
Secondary outcomes:
measure: To determine the safety of the combination of 3 monoclonal antibody infusions as an adjunct to HAART
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: Martin Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rockefeller University Hosp;ital
name: Saurabh Mehandru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rockefeller University
name: Anita Shet, MD
role: PRINCIPAL_INVESTIGATOR
References: