Clinical trial NCT00035581: Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
Official title: A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Seropositivity
HIV Infection
Keywords: treatment experienced
HIV Infections
HIV
HAART
early virologic failure
Lead sponsor: AIM ImmunoTech Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Reduction in HIV-1 Viral Load
timeFrame: 4, 8, 12, 16, 20 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Orange County Center for Special Immunology
state: California
city: Norwalk
country: United States
facility: Circle Medical Center
state: Connecticut
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Julia Torres, MD
state: Florida
city: Tampa
country: United States
facility: Scott Ubillos, MD
state: Florida
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: Reading
country: United States
facility: W. Chris Woodward, DO
state: Pennsylvania
Study officials:
affiliation: AIM ImmunoTech Inc.
name: David R Strayer, MD
role: STUDY_DIRECTOR
References: