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| Sponsored by: |
Rockefeller University |
|---|---|
| Information provided by: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00219986 |
Purpose
Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed HAART-treated individuals who began therapy during acute and early HIV-1 infection.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Potent HAART during acute or early HIV-1 infection |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | September 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
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)
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.
-
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | MMA 520 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00219986 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment Experienced HIV |
|
Antibodies, Monoclonal Virus Diseases Antibodies Sexually Transmitted Diseases, Viral Immunologic Factors HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes Immunoglobulins |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Antibodies, Monoclonal Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
