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An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection


Phase 1
18 Years
60 Years
Not Enrolling
Both
HIV Infections

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Trial Information

An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection


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 instructions given on foods that are allowed; the
second dose is taken at least 3 hours after the evening meal. No snacks are permitted after
the evening meal or after the evening dose of study medication. The study is scheduled to
last for 16 weeks of treatment and 4 weeks of follow-up. Throughout the study, frequent
blood samples will be taken from an arm vein. The blood samples are studied to evaluate any
changes in the patient's immune system, any toxic effects that might be detected in the
blood, and any changes in the presence of the HIV in the blood.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mildvan D

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 022

NCT ID:

NCT00001012

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Virus Replication
  • T-Lymphocytes
  • Dose-Response Relationship, Drug
  • Drug Evaluation
  • Acquired Immunodeficiency Syndrome
  • AL 721
  • AIDS-Related Complex
  • Antiviral Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Los Angeles County - USC Med CtrLos Angeles, California  90033
Louisiana State Univ Med Ctr / Tulane Med SchoolNew Orleans, Louisiana  70112
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Univ of MinnesotaMinneapolis, Minnesota  55455
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
Mount Sinai Med CtrNew York, New York  10029
Beth Israel Med Ctr / Peter Krueger ClinicNew York, New York  10003
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112