Clinical trial NCT00035893: The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Seropositivity
HIV Infection
Keywords: treatment interruption
HIV Infections
Lead sponsor: AIM ImmunoTech Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-07
Enrollment: 40
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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA \< 50 copies/ml (PCR) and CD4 levels \> 400.


Eligibility 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.

Primary outcomes:
measure: HAART-free time interval
timeFrame: HAART adherence questionnaire completed weekly
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Orange County Center for Special Immunology
state: California
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
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: Miami
country: United States
facility: Allied Clinical Trials
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: Somers Point
country: United States
facility: Christopher Lucasti, D.O.
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: