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The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART Clinical research trials and The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART. The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART  The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
For Condition: HIV Infection,HIV Seropositivity
Status: Recruiting
Sponsor(s): Hemispherx Biopharma ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 1. Adults at least 18 years of age. 2. CD4 cell count of > 400 cells. 3. Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline. 4. 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: - Abacavir (Ziagen) - Zidovudine (Retrovir) AZT - Zalcitabine (Hivid) ddC - Didanosine (Videx) ddl - Stavudine (Zerit) d4T - Efavirenz (Sustiva) - Indinavir (Crixivan) - Ritonavir (Norvir) - Nelfinavir (Viracept) - Amprenavir (Agenerase) Only one HIV plasma RNA level > 50, but < 100 copies/ml is permitted during the four month period immediately prior to starting Baseline. 5. Karnofsky performance status of at least 70. 6. The following laboratory parameters within 21 days prior to treatment: - Hemoglobin > 9.2 g/dL for men and > 8.9 g/dL for women; - Neutrophil count > 1000; - Platelet count > 75,000; - AST/ALT < 4.0 x upper limit of normal (ULN); - Serum creatinine < 1.5 x ULN or a creatinine clearance > 50 mL/min. 7. Ability and willingness to give written informed consent. 8. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Females of child bearing potential agree to use an effective means of contraception. 9. The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.
Total Enrollment: 120
Location and Contact Information:
Scott Ubillos, MD *Recruiting*
Tampa, Florida, 33607
United States
Recruiting Jennifer Bailey 813-870-4760
W. Chris Woodward, DO *Recruiting*
Reading, Pennsylvania, 19601
United States
Recruiting Juanita Goodwin 610-378-2552
Dupont Circle Physicians Group *Recruiting*
Washington D.C., District of Columbia, 20009
United States
Recruiting Linda Green 202-745-0201
St. Michael's Medical Center *Recruiting*
Newark, New Jersey, 07102
United States
Recruiting Jim Fallone 973-877-2663
Orange County Center for Special Immunology *Recruiting*
Fountain Valley, California, 92708
United States
Recruiting Sandy Cassarella 714-751-5800
Circle Medical Center *Recruiting*
Norwalk, Connecticut, 06851
United States
Recruiting Ed Hatton 203-852-9525
AIDS Community Research Initiative of America (ACRIA) *Recruiting*
New York City, New York, 10018
United States
Recruiting Salone Howard 212-924-3934
Julia Torres, MD *Recruiting*
Ft. Lauderdale, Florida, 33306
United States
Recruiting Miguel Brito 954-568-2929
Additional Information:
Study ID Numbers: AMP 720;
Study Start Date: April 2001
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035893
Other Hiv Infection Studies:
1. Genetically Modified Lymphocytes to Treat HIV-infected Identical Twins - Study Modifications
2. Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients
3. Stem Cell (Modified Bone Marrow) Transplantation in HIV-Infected Patients with Blood Cancer
4. Correlation of HIV Levels with Clinical and Immunologic Outcome in Children Treated with Didanosine
5. Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection
Related Studies:
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The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
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