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Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed HAART-treated individuals who began therapy during acute and early HIV-1 infection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potent HAART during acute or early HIV-1 infection | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the antiviral activity of the combination of 3 monoclonal antibody infusions as an adjunct to HAART |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety of the combination of 3 monoclonal antibody infusions as an adjunct to HAART |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Markowitz, MD | Rockefeller University | Principal Investigator |
| Saurabh Mehandru, MD | Rockefeller University Hosp;ital | Principal Investigator |
| Anita Shet, MD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University Hospital | New York | New York | 10021 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |