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

NCT00219986 | Completed Phase 1

• 1 other identifier: MMA 520
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Treatment Experienced; HIV

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Potent HAART during acute or early HIV-1 infection DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Martin Markowitz, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

• Saurabh Mehandru, MD

  Rockefeller University Hosp;ital

  PRINCIPAL INVESTIGATOR

• Anita Shet, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2003
• Study Completion: September 1, 2005
• Last Updated: July 18, 2007

Record last verified: 2005-09

Locations

US (1)