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Clinical Research Studies at the AIDS Research Consortium of Atlanta (ARCA)

May 2001

The following studies are currently enrolling patients.

    Naïve (N) -- no anti-HIV drug experience
    Minimal (M) -- minimal anti-HIV drug experience
    Experienced (E) -- have taken anti-HIV drugs


DAPD (E)
This study looks at an anti-HIV drug that appears to work against HIV that is resistant to 3TC, AZT and d4T. This study will test DAPD's safety, how well patients tolerate the drug, and how well DAPD works against HIV. Involvement in this study lasts for 22 days and involves 12 study visits. Two of the visits are 12 hours each. Study visits, lab tests, procedures and study drugs are provided at no cost. Patients will be reimbursed a fee for time and travel related expenses.
Viral load between 4,000 and 250,000 copies
T-cell count > 50


ESS40006 (E)
This study looks at combination therapy of two doses of amprenavir, along with ritonavir and abacavir. Patients will also receive either tenofavir or efavirenz depending on previous NNRTI experience, as well as one NRTI. three different drug combinations for the treatment of HIV. Involvement in this study will last about one year and involve about 12 study visits. The drugs (except the NRTI to be prescribed), visits, physical exams, and lab tests that are part of this study will be provided to you at no cost while taking part in the study. Patients and/or their insurance will be responsible for the cost of the NRTI.
T-Cell ( 50, Viral Load ( 1,000 ( 50,000

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NNRTI Combo Study (N)
This study looks at how well certain combinations of approved drugs work against HIV. The drugs used in this study will be efavirenz (Sustiva®), nevirapine (Viramune®), 3TC, and d4T. All patients will receive 3TC and d4T. Patients will then receive either nevirapine, efavirenz, or nevirapine plus efavirenz. This study will last about 48 weeks and involves about 12 visits. Study visits, lab tests, procedures, and study drugs (efavirenz, nevirapine, 3TC and d4T) will be provided at no cost to patients.
Viral Load > 5,000 copies


REMUNE 202 (N)
REMUNE is a new vaccine that is made from an inactivated (killed) HIV-1 virus. This new vaccine is given by injection, and is not approved by the FDA. It is thought that the REMUNE vaccine boosts the body's natural immune system. This study will see if adding REMUNE to a highly aggressive anti-HIV therapy (Viracept® and CombivirTM [AZT+3TC]) will lengthen the amount of time until a patient needs to change to a new drug treatment. The study drugs, visits, and lab tests will be provided at no charge.
T-Cell ( 250 , Viral Load ( 10,000


SILCAAT (M, E)
This study looks at how a new form of IL-2 (Interleukin) called Proleukin works with anti-HIV therapy to slow HIV disease. Proleukin is not yet approved by the FDA for the treatment of HIV. IL-2 is a substance that is naturally made by the body's T-Cell cells (T-Cells). The IL-2 used in this study is man-made and is given by an injection under the skin. Patients may be enrolled in this study for up to six years; and half of the patients will receive the study drug in addition to their anti-HIV therapy. The other half of the patients will remain on their anti-HIV therapy without the IL-2. The IL-2, study visits and laboratory tests are provided at no cost. Patients and/or their insurance companies are responsible for the anti-HIV therapy.
T-Cell ( 50 ( 300, Viral Load ( 10,000


T-20 SALVAGE (Fusion Inhibitor) (E)
T-20 is given by injection and acts by not allowing HIV to get into a healthy cell. This study looks at how T-20 works when added to an optimal anti-HIV drug regimen chosen by you and your doctor. Two out of every three patients will receive study drug. The patient or their company will be responsible for the costs of your other anti-HIV drugs. During the study, patients will have two screening visits, and then about 16 visits over 48 weeks. Three longer visits are required as a part of this study. Patients will be reimbursed for these three longer visits. Study drug (T-20), visits, lab work, and any procedures will be provided at no cost to patients.
Viral Load (5000 copies


Serostim (Recombinant Hormone) (E)
This is a study of a growth hormone given by injection that is approved by the FDA for use in managing growth hormone deficiency, but is experimental for use in HIV. This study will see how the study drug affect the size of abnormal fat deposits in the body. There are two treatment periods of twelve weeks each. During each twelve week period patients will be assigned at random to receive either study drug (2 groups) or placebo (1 group). During the second treatment period each patient will be switched to a different group so all patients will receive active study drug during at least one of the study periods. This study also involves several types of testing including a Glucose Tolerance Test (GTT), CT Scan, DEXA Scan, ECG and optional photographs of body shape. During the study, patients will have about six visits over 24 weeks. Patients will be reimbursed for visits with GTT, CT and DEXA scans. The study provides study drug (Serostim), study visits, lab work and procedures. The patient or their insurance company will be responsible for your anti-HIV drugs.


APV30002 (Amprenavir Prodrug) (N)
This is a study of a new Amprenavir Prodrug. Prodrug means that the drug converts to Amprenavir once it is in the body. This study will compare the Amprenavir Prodrug and Nelfinavir in combination with Abacavir and 3TC. The study will last at least 48 weeks, but could last up to two years depending on when the last enrolled patient finishes. Patients will have at least 14 study visits during the first 48 weeks and additional visits every 8 weeks beyond the first 48 weeks. Study drugs, visits, exams and lab tests are provided at no cost.
Viral Load ( 1,000

*A placebo is a pill or liquid made to look like a medication, but that contains no active drug.

Please call ARCA (404-876-2317) for more information about these or any other new studies that may have begun enrolling after the print deadline.




  
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This article was provided by AIDS Survival Project. It is a part of the publication Survival News.
 

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