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| Sponsor: | Hemispherx Biopharma |
|---|---|
| Information provided by: | Hemispherx Biopharma |
| ClinicalTrials.gov Identifier: | NCT00035581 |
Purpose
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Seropositivity HIV Infection |
Drug: (Ampligen) polyI-polyC12U |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
HIV-1 plasma RNA >500 and <30,000 copies/ml.
A qualifying ("screening") HIV-1 RNA level >500 and <30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:
The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.
The following laboratory parameters within 14 days prior to treatment:
Contacts and Locations| United States, California | |
| Orange County Center for Special Immunology | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact: Sandy Cassarella 714-751-5800 ext 26 | |
| Principal Investigator: Paul J Cimoch, MD | |
| United States, Connecticut | |
| Circle Medical Center | Recruiting |
| Norwalk, Connecticut, United States, 06851 | |
| Contact: Ed Hatton 203-852-9525 | |
| Principal Investigator: Gary Blick, MD | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group | Recruiting |
| Washington, District of Columbia, United States, 20009 | |
| Contact: Linda Green 202-745-0201 | |
| Principal Investigator: Douglas Ward, MD | |
| United States, Florida | |
| Julia Torres, MD | Recruiting |
| Fort Lauderdale, Florida, United States, 33306 | |
| Contact: Miguel Brito 954-568-2929 | |
| Principal Investigator: Julia Torres, MD | |
| Scott Ubillos, MD | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Jennifer Bailey 813-870-4760 | |
| Principal Investigator: Scott Ubillos, MD | |
| United States, New Jersey | |
| St. Michael's Medical Center | Recruiting |
| Newark, New Jersey, United States, 07102 | |
| Contact: Jim Fallone 973-877-2663 | |
| Principal Investigator: Jihad Slim, MD | |
| United States, New York | |
| AIDS Community Research Initiative of America (ACRIA) | Recruiting |
| New York, New York, United States, 10018 | |
| Contact: Salone Howard 212-924-3934 | |
| Principal Investigator: Jerome Ernst, MD | |
| United States, Pennsylvania | |
| W. Chris Woodward, DO | Recruiting |
| Reading, Pennsylvania, United States, 19601 | |
| Contact: Juanita Goodwin 610-378-2552 | |
| Principal Investigator: W. Chris Woodward, DO | |
More Information
| Study ID Numbers: | AMP 719 |
| Study First Received: | May 3, 2002 |
| Last Updated: | August 17, 2005 |
| ClinicalTrials.gov Identifier: | NCT00035581 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
treatment experienced HIV Infections HIV HAART early virologic failure |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Ampligen Virus Diseases HIV Seropositivity HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
