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Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART

NCT00035581 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-04-17

No results posted yet for this study

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).

Conditions

  • HIV Seropositivity
  • HIV Infection

Interventions

DRUG

poly I-poly C12U

200-400 mg IV infusions 2x/week for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • David R Strayer, MD · AIM ImmunoTech Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00035581 on ClinicalTrials.gov