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| Sponsor: | Hemispherx Biopharma |
|---|---|
| Information provided by: | Hemispherx Biopharma |
| ClinicalTrials.gov Identifier: | NCT00035893 |
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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Seropositivity HIV Infection |
Drug: (Ampligen) polyI-polyC12U |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
History of virologic success with suppression of HIV RNA level < 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a HAART regiment. During the four months prior to starting Baseline, continuing through Baseline and the 64 week study period, the HAART regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs:
Only one HIV plasma RNA level > 50, but < 100 copies/ml is permitted during the four month period immediately prior to starting Baseline.
The following laboratory parameters within 21 days prior to treatment:
Contacts and Locations| United States, California | |
| Orange County Center for Special Immunology | |
| Fountain Valley, California, United States, 92708 | |
| AltaMed Health Services Corporation | |
| Los Angeles, California, United States, 90022 | |
| United States, Connecticut | |
| Circle Medical Center | |
| Norwalk, Connecticut, United States, 06851 | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| Julia Torres, MD | |
| Fort Lauderdale, Florida, United States, 33306 | |
| Allied Clinical Trials | |
| Miami, Florida, United States, 33156 | |
| Scott Ubillos, MD | |
| Tampa, Florida, United States, 33607 | |
| United States, New Jersey | |
| St. Michael's Medical Center | |
| Newark, New Jersey, United States, 07102 | |
| Christopher Lucasti, D.O. | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, Pennsylvania | |
| W. Chris Woodward, DO | |
| Reading, Pennsylvania, United States, 19601 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00035893 History of Changes |
| Other Study ID Numbers: | AMP 720 |
| Study First Received: | May 6, 2002 |
| Last Updated: | April 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
treatment interruption HIV Infections |
|
HIV Infections Acquired Immunodeficiency Syndrome HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ampligen Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |