An open-label, dose-ranging trial of AL 721 in patients with persistent generalized lymphadenopathy and AIDS-related complex
Article Abstract:
Active lipid 721 (AL 721) is an egg yolk extract which has been shown to inhibit the growth of human immunodeficiency virus (HIV) in laboratory tests. AL 721 has been tested in small clinical trials with conflicting results. A large trial was therefore conducted with 40 men with persistent generalized lymphadenopathy or AIDS-related complex, testing various doses of AL 721, ranging from 20 to 50 grams and given twice daily for eight weeks. The participants in the trial were being treated at various medical centers in the United States. AL 721 did not cause severe side effects. The side effects that did occur involved the gastrointestinal tract, such as diarrhea, which was mild to moderate in severity and was self-limited, lasting up to 48 hours. Patients taking the compound gained weight but lost the weight again, usually within four weeks after the treatment regimen was ended. Treatment with AL 721 did not restore the function of the immune system, as determined by examining the levels of various subsets of T lymphocytes, which are altered during HIV infection. Virus was cultured from cells of the infected individuals after the treatment and the virus was still able to grow. Therefore, AL 721 did not have any effects on the virus. The levels of lipids in the blood, including triglycerides and cholesterol, were increased, which would be detrimental to the blood vessels and heart in the long-term. Therefore, AL 721 did not show any positive effects when used for the treatment of persistent generalized lymphadenopathy or AIDS-related complex. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of Acquired Immune Deficiency Syndromes
Subject: Health
ISSN: 0894-9255
Year: 1991
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Functional status and well-being in a placebo-controlled trial of zidovudine in early symptomatic HIV infection
Article Abstract:
Zidovudine (AZT) may actually cause a decline in well-being and quality of life during the first few months of treatment. Of 70 men with early HIV infection, 36 began taking 1,200 milligrams of zidovudine daily and 34 took an identical placebo, or inactive substance. At 24 weeks, the men taking the placebo rated their overall health, energy and quality of life as better than at the start of the study. However, the men taking zidovudine said their overall health and energy had declined since the start of the study. At 36 weeks, both groups had reverted back to their baseline values, and by 52 weeks, both groups rated their overall health and quality of life as worse. At no time during the study did the men taking zidovudine feel better than those taking a placebo. Lower doses of zidovudine may eliminate this adverse effect on well-being in early HIV infection.
Publication Name: Journal of Acquired Immune Deficiency Syndromes
Subject: Health
ISSN: 0894-9255
Year: 1993
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Psychological effects of participation and nonparticipation in a placebo-controlled zidovudine clinical trial with asymptomatic human immunodeficiency virus-infected individuals
Article Abstract:
Asymptomatic HIV-infected individuals who participate in clinical trials may be less depressed and anxious than those who do not. A clinical trial is a research study that evaluates a new medical procedure or drug using human volunteers. Among 73 asymptomatic HIV-infected individuals, 46 participated in a clinical trial of zidovudine (AZT) and 27 did not (control group). The individuals were evaluated for depression and anxiety at the beginning of the clinical trial, at two months and six months, and after the protocol of the clinical trial was modified. Individuals in the clinical trial were less depressed and anxious after six months, but those in the control group were less depressed only. After modification of the clinical trial protocol, the clinical trial participants were less depressed and anxious than individuals in the control group.
Publication Name: Journal of Acquired Immune Deficiency Syndromes
Subject: Health
ISSN: 0894-9255
Year: 1993
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