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The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral
zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine
the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and
AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1
appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte
maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients
receiving AZT and PEG IL-2.
Stanford is currently not accepting patients for this trial.
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Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with
increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent
generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or
toxicity, how quickly the drugs are used in the body, effects on the immune system, effects
on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys.
The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to
determine the dose that has the greatest effect in the immune system.
AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase
immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also
been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical
activities of these two drugs and because their toxicities and mechanisms of action do not
overlap, it may be beneficial to combine the two drugs with their antiviral and immune
An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by
continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of
BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose
related antiviral activity determined by quantitation of infectious HIV peripheral blood
leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when
present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is
a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4
binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction.
Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is
necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date,
Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant
soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to
distinguish between these two products, a change in nomenclature has been made. In this
protocol, whenever the original sequence CD4 molecule is referred to, it is called
recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study
in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed
generically, it is referred to as rsCD4.
A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose
schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic
HIV-infected patients. Because of the failure with long-term (more than 1 year) use of,
frequency of toxicity from, and drug resistance to AZT, drug combinations need to be
developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the
development of resistance, while providing at least the same effectiveness.
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or
biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of
PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV
virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who
complete the initial 25-week regimen.
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating
viral replication (reproduction and growth). A main thrust of current treatment is the
combination of antiviral drugs that may be more effective when combined than when each is
Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
To validate that the alteration of codon 215 of reverse transcriptase in plasma virus
precedes the increase in viral burden as measured in the peripheral blood and the decline in
CD4 count that have been observed in association with clinical failure on zidovudine (AZT).
To determine whether alternative regimens of antiretroviral agents alter the course of viral
burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To
obtain further data on the safety and immunologic and virologic response to
Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at
codon 215 of the reverse transcriptase gene is the most commonly occurring and has the
greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent
further immunologic and virologic deterioration.
A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the
disease process in hemophilic patients who have HIV infection with no symptoms. The major
clinical question is whether patients who receive chronic ZDV therapy will have a delay in
the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of
ZDV in hemophilic patients will also be studied.
Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to
his wife or other female sexual partner. To determine the effectiveness of counseling and
education on the behaviors of the wives that place them at risk for HIV infection. To
determine if antibodies to HIV either appear or disappear from the blood of any of the wives
during the study.
Study A: Individuals who are infected with HIV can benefit from therapy with an effective
anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in
humans at the dose planned. It may be effective in preventing the development of AIDS or ARC
in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are
especially important because the high prevalence of hepatic disease in this population may
affect the metabolism and blood levels of ZDV.
Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have
become infected during long-term sexual relationships. Transmission of the virus does not
occur during casual family contact. This study will aid in determining if therapy influences
the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV
infection other than sexual contact with their spouse.