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

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00001012
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To study the tolerance and safety of increasing doses of AL-721 in patients with persistent generalized lymphadenopathy (PGL) and symptomatic HIV infection, and to obtain preliminary information on the effectiveness of AL-721 against the human immunodeficiency virus (HIV) in HIV-infected persons with PGL 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (9)

Beth Israel Med Ctr / Peter Krueger Clinic; 🇺🇸 New York, New York, United States

Mem Sloan - Kettering Cancer Ctr; 🇺🇸 New York, New York, United States

Mount Sinai Med Ctr; 🇺🇸 New York, New York, United States

Bronx Veterans Administration / Mount Sinai Hosp; 🇺🇸 Bronx, New York, United States

Los Angeles County - USC Med Ctr; 🇺🇸 Los Angeles, California, United States

Charity Hosp / Tulane Univ Med School; 🇺🇸 New Orleans, Louisiana, United States

Louisiana State Univ Med Ctr / Tulane Med School; 🇺🇸 New Orleans, Louisiana, United States

Tulane Univ School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Univ of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States