Phase I/II, Open-Label Trial of Three Monoclonal Antibodies
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00219986 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: July 18, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Potent HAART during acute or early HIV-1 infection | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | October 2003 |
Study Completion Date : | September 2005 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219986
United States, New York | |
Rockefeller University Hospital | |
New York, New York, United States, 10021 |
Principal Investigator: | Martin Markowitz, MD | Rockefeller University | |
Principal Investigator: | Saurabh Mehandru, MD | Rockefeller University Hosp;ital | |
Principal Investigator: | Anita Shet, MD | Rockefeller University |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00219986 History of Changes |
Other Study ID Numbers: |
MMA 520 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | July 18, 2007 |
Last Verified: | September 2005 |
Keywords provided by Rockefeller University:
Treatment Experienced HIV |
Additional relevant MeSH terms:
Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |