Search / Trial NCT00001012

A Study of AL721 in HIV-Infected Patients With Swollen Lymph Nodes

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Virus Replication T Lymphocytes Dose Response Relationship, Drug Drug Evaluation Acquired Immunodeficiency Syndrome Al 721 Aids Related Complex Antiviral Agents

ClinConnect Summary

Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated.

Patients receive AL-721 twice daily. The first dose is taken on an empty stomach 1 hour before a fat-free breakfast, with specific ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Persistent generalized lymphadenopathy (PGL) (CDC-Group III), defined as palpable lymphadenopathy (nodes of 1 cm or greater) at two or more noncontiguous extrainguinal sites persisting for \> 3 months in the absence of an illness other than HIV infection to account for the findings.
  • * AIDS related complex (ARC), defined as the presence of at least one of the following findings within 12 months prior to entry and the absence of a concurrent illness or condition other than HIV infection to explain the findings:
  • Any findings which define CDC-Group IV A.
  • History of any one of the findings that define CDC-Group IV C2.
  • Patients with any of the ARC symptoms can also have PGL and be enrolled in the protocol as ARC patients.
  • A positive antibody to HIV by any federally licensed ELISA test kit within 30 days of entry.
  • Concurrent Medication: Allowed:
  • Topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study.
  • Exclusion Criteria
  • Exclude hemophiliacs.
  • Active substance abuse.
  • Alcohol consumption should be kept to a minimum.
  • Co-existing Condition:
  • Patients with the following will be excluded:
  • Hemophilia.
  • History or presence of an AIDS-defining opportunistic infection or malignancy.
  • AIDS related complex (ARC) patients with prior (within the last 12 months) or current history of diarrhea defined as = or \> 3 liquid stools per day persisting for longer than 1 month.
  • * Significant malabsorption:
  • Greater than 10 percent weight loss within past 3 months with serum carotene \< 75 IU/ml or vitamin A \< 75 IU/ml.
  • Significant cardiac, liver, renal, or neurologic disorder.
  • Active ARC-defining secondary infection (oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia or Nocardiosis) undergoing therapy or prophylaxis within 7 days of study entry.
  • Active tuberculosis under treatment.
  • Concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Concurrent Medication:
  • Excluded:
  • Any medication that will interfere with the assessment of AL-721, including nutritional supplements, vitamins, laxatives, and over-the-counter products containing lecithin.
  • Chemoprophylaxis for Pneumocystis carinii (PCP), candida, herpes simplex, herpes zoster infections, or bacterial infections.
  • Intravenous topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study.
  • Systemic chemotherapy.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Any investigational drug.
  • Biologic response modifiers.
  • Corticosteroids.
  • Chemotherapeutic agents.
  • * Excluded within 90 days of study entry:
  • Any antiretroviral agent or AL-721.

Trial Officials

Mildvan D

Study Chair

Armstrong D

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

New York, New York, United States

New York, New York, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Bronx, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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