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Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART Clinical research trials and Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART. Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART clinical trial. Human subjects often get the best healthcare possible for their Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART  Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing 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 "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
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 >300 cells. 3. 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: - Abacavir (Ziagen) - Zidovudine (Retrovir) AZT - Zalcitabine (Hivid) ddC - Didanosine (Videx) ddI - Stavudine (Zerit) d4T - Efavirenz (Sustiva) - Indinavir (Crixivan) - Ritonavir (Norvir) - Nelfinavir (Viracept) - Amprenavir (Agenerase) The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination. 4. History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI). 5. Karnofsky performance status of at least 70. 6. The following laboratory parameters within 14 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. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.
Total Enrollment: 130
Location and Contact Information:
St. Michael's Medical Center *Recruiting*
Newark, New Jersey, 07102
United States
Recruiting Jim Fallone 973-877-2663
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
Orange County Center for Special Immunology *Recruiting*
Fountain Valley, California, 92708
United States
Recruiting Sandy Cassarella 714-751-5800
Scott Ubillos, MD *Recruiting*
Tampa, Florida, 33607
United States
Recruiting Jennifer Bailey 813-870-4760
Dupont Circle Physicians Group *Recruiting*
Washington D.C., District of Columbia, 20009
United States
Recruiting Linda Green 202-745-0201
W. Chris Woodward, DO *Recruiting*
Reading, Pennsylvania, 19601
United States
Recruiting Juanita Goodwin 610-378-2552
Julia Torres, MD *Recruiting*
Ft. Lauderdale, Florida, 33306
United States
Recruiting Miguel Brito 954-568-2929
Additional Information:
Study ID Numbers: AMP 719;
Study Start Date: July 2001
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035581
Other Hiv Seropositivity Studies:
1. Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients
2. Analysis of HIV Genetic Variation in Patients Before Beginning Highly Active Antiretroviral Therapy
3. HIV Maintenance Therapy with T-20 During HAART Interruption
4. The Effect of Milk Thistle on the Pharmacokinetics of Indinavir
5. Kidney Transplant for HIV-Infected Patients in Renal Failure
Related Studies:
Other HIV Seropositivity Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
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