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The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00035893
Enrollment
40
Registered
2002-05-07
Start date
2001-05-31
Completion date
2006-08-31
Last updated
2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, HIV Seropositivity

Keywords

treatment interruption, HIV Infections

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.

Interventions

200-400 mg IV infusions 2x/week for 64 weeks

Sponsors

AIM ImmunoTech Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
HAART-free time intervalHAART adherence questionnaire completed weeklyTo evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026