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AMP 720

 

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

Design:
This is an open-label, prospective, randomized, controlled study of the safety and biological effects, including clinical, immunologic, and virologic assessments of adding Ampligen® 400 mg to a STI protocol of HAART containing at least one (1) of the following ten (10) antiretroviral drugs in patients with plasma HIV RNA < 50 and CD4 levels 400:

1. Abacavir (Ziagen) 1 6. Efavirenz (Sustiva)
2. Zidovudine (Retrovir) AZT 1,2 7. Indinavir (Crixivan)
3. Zalcitabine (Hivid) ddC 8. Ritonavir (Norvir) 3
4. Didanosine (Videx) ddI 9. Nelfinavir (Viracept)
5. Stavudine (Zerit) d4T 10. Amprenavir (Agenerase)

Note:
1 Trizivir counts for two of the required anti-retroviral drugs.
2 Combivir counts for one of the required anti-retroviral drugs.
3 Kaletra counts for none.


All patients will be on a HAART regimen that has suppressed HIV plasma RNA below the limits of detection (< 50 copies/ml) during the last nine (9) months or longer. Following eight (8) weeks of Ampligen® or No Ampligen®, HAART will be discontinued and patients will be monitored weekly for HIV rebound (i.e. - HIV plasma RNA) > 5000 copies/ml for three (3) consecutive weeks or > 50,000 on one occasion). Following HIV rebound, HAART will be restarted. Eight (8) weeks after the plasma HIV RNA becomes undetectable, a second STI will be introduced and monitored identically to the initial STI. This sequence will be replicated for the full 64 week trial period. Thus, each subject in both arms of the trial will establish their own HAART-free time intervals during the sequential STI.

Objectives:

Primary:
To evaluate the potential effectiveness of Ampligen® to increase the HAART-free time interval before HIV rebound during the STI of HAART .

Secondary:

  1. To evaluate potential immunologic benefit of adding Ampligen® on the CD4 level
     
  2. To evaluate the affect of Ampligen® on the magnitude of HIV rebound following each STI.
     
  3. To collect clinical information including adherence to HAART, Quality of Life parameter, and HAART related toxicities as a function of the HAART-free time interval
     
  4. To evaluate the safety and tolerance of adding Ampligen® to HAART

Patient Eligibility:

Inclusion Criteria:

  1. Adults 18 years of age with positive serology for HIV confirmed by Western blot analysis
     
  2. CD4 cell count of 400 cells/mm3 : Two CD4 cell determinations 400 cells/mm3 or one (1) 500 within six (6) weeks of starting Baseline will qualify patient for CD4 cell count 400 cells/mm3
     
  3. Plasma HIV-1 RNA < 50 copies/ml using the Ultra Sensitive assay (Roche) on two occasions: one within the six (6) weeks prior to starting Baseline and the other during Baseline at week three (3)
     
  4. History of virologic success with suppression of HIV RNA level < 50 copies/ml during the last nine (9) months documented a minimum of two (2) times during the last ten (10) months or a minimum of three (3) times during the last fifteen (15) months while patient is receiving a HAART regimen. During the four (4) 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 (1) of the following ten (10) anti-retroviral drugs:
     

    1. Abacavir (Ziagen) 1 6. Efavirenz (Sustiva)
    2. Zidovudine (Retrovir) AZT 1,2 7. Indinavir (Crixivan)
    3. Zalcitabine (Hivid) ddC 8. Ritonavir (Norvir) 3
    4. Didanosine (Videx) ddI 9. Nelfinavir (Viracept)
    5. Stavudine (Zerit) d4T 10. Amprenavir (Agenerase)
    Note:
    1 Trizivir counts for two of the required anti-retroviral drugs.
    2 Combivir counts for one of the required anti-retroviral drugs.
    3 Kaletra counts for none.


    Only one HIV plasma RNA level 50, but < 100 is permitted during the four (4) month period immediately prior to starting Baseline.
     
  5. Karnofsky performance status 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 cells/mm3
    • Platelet count 75,000 platelets/mm3
    • 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 the first study medication infusion. 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


Exclusion Criteria:

  1. Patients with a history of AIDS
     
  2. Patients with active malignancy or history of malignancy other than minimal Kaposi sarcoma or basal cell carcinoma
     
  3. Subjects with history of prior Ampligen® treatment
     
  4. Pregnant women, or women who intend to become pregnant during this study, or women who are breastfeeding
     
  5. Systemic corticosteroid therapy given for > 21 consecutive days within 60 days prior to first dose of study drug
     
  6. Any investigational drug within 60 days prior to first dose of study drug
     
  7. Inadequately controlled seizure disorder
     
  8. Active alcohol or other substance abuse or another condition which investigator deems would prevent adequate study compliance
     
  9. A recent surgery, trauma, or childbirth within eight (8) weeks of starting Baseline

Status:
Active - Closed to enrollment



Please contact Hemispherx Biopharma in writing for additional information regarding trial locations and site contacts:
 

By Fax: 215-988-1739
By E-Mail: trialinfo@hemispherx.net
By Mail: One Penn Center
1617 JFK Blvd., 6th Floor
Philadelphia, PA 19103