December 19, 1997
ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ NEW INFORMATION FROM ACTIS
The AIDS Clinical Trials Information Service (ACTIS) is a
resource service providing current information on federally and
privately sponsored clinical trials for AIDS patients and others
infected with HIV.ÿ This service is a Public Health Service
project collaboratively sponsored by the Centers for Disease
Control and Prevention, the Food and Drug Administration, the
National Institute of Allergy and Infectious Diseases, and the
National Library of Medicine.
A description of a clinical trial recently added to the ACTIS
database is provided below.
For more information, call the ACTIS toll-free number to talk
with a health specialist.ÿ On request, you can also obtain a
printout of a customized search of the clinical trials databases.
The information can also be accessed directly by subscribers
through two online databases, AIDSTRIALS and AIDSDRUGS, available
through the National Library of Medicine.
ÿÿÿÿÿÿÿÿÿÿÿ AIDS CLINICAL TRIALS INFORMATION SERVICE
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1) NIAID ACTG 353: A Phase I Trial of the Safety, Tolerance, and
ÿÿÿÿ Pharmacokinetics of Oral Nelfinavir (Viracept)
ÿÿÿÿ Co-Administered with Zidovudine (ZDV) and Lamivudine (3TC)
ÿÿÿÿ in HIV-Infected Pregnant Women and Their Infants.
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PROTOCOL NUMBER: NIAID ACTG 353.
TITLE:
A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of
Oral Nelfinavir (Viracept) Co-Administered with Zidovudine (ZDV)
and Lamivudine (3TC) in HIV-Infected Pregnant Women and Their
Infants.
PHASE: Phase I.
DISEASE STATUS:
Patients must have the following conditions and symptoms: HIV
infection documented by ELISA antibody test and confirmed by an
appropriate test (e.g., Western Blot). NOTE: Source documentation
is acceptable if hard copies are obtained.
PATIENT INCLUSION CRITERIA
--------------------------
SPECIFICATION CRITERIA:
Patients must have:
ÿÿÿÿ 1. HIV infection documented by ELISA antibody test and
ÿÿÿÿ confirmed by an appropriate test (e.g., Western Blot). NOTE:
ÿÿÿÿ Source documentation is acceptable if hard copies are
ÿÿÿÿ obtained.
ÿÿÿÿ 2. Gestational age of 14 to 34 for singleton pregnancies OR
ÿÿÿÿ gestational age of 14 to 30 weeks for twin pregnancies,
ÿÿÿÿ based upon menstrual history and confirmed by an early
ÿÿÿÿ ultrasound or serial sonographic determinations. NOTE:
ÿÿÿÿ Gestational age given by the date of the last menstrual
ÿÿÿÿ period and that given by the ultrasound must be within 14
ÿÿÿÿ days of each other in the second trimester and within 21
ÿÿÿÿ days of each other for those pregnancies > 24 weeks.
ÿÿÿÿ 3. A normal level II/targeted fetal ultrasound at > 18 weeks
ÿÿÿÿ gestation.
ÿÿÿÿ 4. Signed, informed consent fromÿ parent or legal guardian
ÿÿÿÿ for patients under 18 years of age.
[Refer to Laboratory values for additional requirements.]
AGE: 13 Years - 99 Years.
SEX: F.
REPRODUCTIVE SPECIFICATION:
Women in the first or second trimester of pregnancy.
WEIGHT: Infants: >= 2 kg.
PRIOR MEDICATION:
Allowed:
ÿÿÿÿ Prior treatment alone or in combination with didanosine,
ÿÿÿÿ dideoxycytidine, stavudine, or ZDV.
LABORATORY VALUES AT ENTRY
--------------------------
HEMOGLOBIN:ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ >= 8.5 g/dl.
PLATELET COUNT:ÿÿÿÿÿÿÿÿÿÿÿÿÿÿ > 50,000 platelets/mm3.
CD4 (T4 CELL) COUNT:ÿÿÿÿÿÿÿÿÿ Unspecified cells/mm3.
SGPT (ALT):ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ <= 3 X ULN. (ULN = Upper limit of
ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ normal)
CREATININE:ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ <= 1.5.
OTHER LABORATORY VALUES:ÿÿÿÿÿ ANC >= 1,000 cells/mm3.ÿ Amylase <=
ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ 1.5 X ULN with normal lipase.
PATIENT EXCLUSION CRITERIA
--------------------------
SPECIFICATION CRITERIA:
[Refer to Laboratory values for additional requirements.]
AGE:ÿ 01 Days - 12 Years.
SEX:ÿ M.
REPRODUCTIVE SPECIFICATION:
Not pregnant.
WEIGHT: Infants: < 2 kg.
RISK BEHAVIOR:
Excluded: Substance or alcohol abuse.
PRIOR MEDICATION:
Excluded:
ÿÿÿÿ 1. Prior protease inhibitor therapy.
ÿÿÿÿ 2. 3TC prior to pregnancy or for > 3 weeks during this
ÿÿÿÿ pregnancy.
ÿÿÿÿ 3. Non-nucleoside reverse transcriptase inhibitors within 2
ÿÿÿÿ weeks prior to study entry (2-week washout period required
ÿÿÿÿ if given within 2 weeks of entry).
CONCURRENT MEDICATION:
Excluded:
ÿÿÿÿ Rifampin, rifabutin, terfenadine, astemizole, cisapride,
ÿÿÿÿ triazolam, midazolam, ergot derivatives, amiodarone,
ÿÿÿÿ quinidien, and anti-seizure and anti-cancer medications.
CO-EXISTING CONDITIONS OR DISEASES:
Patients with the following conditions or symptoms are excluded:
Women:
ÿÿÿÿ 1. Triplet or higher order gestation.
ÿÿÿÿ 2. Intolerance to ZDV or 3TC.
ÿÿÿÿ 3. Active opportunistic infection, serious bacterial
ÿÿÿÿ infection, or unstable or severe medical condition.
ÿÿÿÿ 4. Chronic malabsorption or chronic diarrhea.
ÿÿÿÿ 5. Acute diarrhea ( > 6 loose stools/day for >= 7 days
ÿÿÿÿ within one month of entry).
ÿÿÿÿ 6. Intrauterine growth restriction < third percentile for
ÿÿÿÿ gestational age.
ÿÿÿÿ 7. Abnormal amniotic fluid volume upon entry.
ÿÿÿÿ 8. Participation in other therapeutic or vaccine perinatal
ÿÿÿÿ treatment trial during current pregnancy.
ÿÿÿÿ 9. Family history of phenylketonuria (PKU).
Infants:
ÿÿÿÿ 10. Severe congenital malformations or other conditions
ÿÿÿÿ incompatible with life.
AVAILABILITY:
Excluded:
ÿÿÿÿ Unable to access the same participating ACTU for the study
ÿÿÿÿ duration.
GENERIC DRUG NAME
-----------------
Drug 1: Zidovudine. Antiretroviral.
Drug 2: Lamivudine. Antiretroviral.
Drug 3: Nelfinavir. Protease inhibitor.
DRUG TRADE NAME
---------------
Drug 1: Retrovir.
Drug 2: Epivir.
Drug 3: Viracept.
DRUG COMPANIES
--------------
Drug 1: Glaxo Wellcome
5 Moore Drive / PO Box 13398
Research Triangle Park, NC 27709
Contact: Department of Consumer Affairsÿÿÿ (800) 437-0992 X 7900.
Drug 2: Glaxo Wellcome
5 Moore Drive / PO Box 13398
Research Triangle Park, NC 27709
Contact: Department of Consumer Affairsÿÿÿ (800) 437-0992 X 7900.
Drug 3: Agouron Pharmaceuticals Incorporated
10350 North Torrey Pines Road / Suite 100
La Jolla, CA 92037
Contact: Unspecifiedÿÿ (888) 847-2237.
END POINT
---------
Pharmacokinetics, safety, and tolerance.
DISCONTINUE TREATMENT
---------------------
Patients may be discontinued for the following reasons:
ÿÿÿÿ 1. Unacceptable toxicity.
ÿÿÿÿ 2. Further participation would be detrimental to patient.
Women:
ÿÿÿÿ 3. Refusal of further treatment and/or evaluations.
ÿÿÿÿ 4. Failure to comply so as to cause harm to self or serious
ÿÿÿÿ interference with the validity of the results.
Infants:
ÿÿÿÿ 5. Legal guardian refuses further treatment or follow-up.
ÿÿÿÿ 6. Unable to tolerate oral medications for a 72-hour period.
ÿÿÿÿ 7. Treatment discontinuation of mother prior to birth.
ÿÿÿÿ 8. Severe anemia or hypovolemia requiring volume replacement
ÿÿÿÿ and/or blood products.
ÿÿÿÿ 9. Documented or suspected serious infections, cardiac,
ÿÿÿÿ respiratory, or metabolic illness, or other immediate life
ÿÿÿÿ threatening condition.
PARTICIPATING UNITS
-------------------
0000002298:
Baystate Medical Center of Springfield
759 Chestnut Street / SHU-Main 3
Springfield, MA 01199
Contact: MariPat Toyeÿ (413) 784-5399
OPEN 971016 ACTU: 7302.
0000001289:
San Juan City Hospital
Centro Medico / Mail Station 128 / GPO Box 70344
San Juan, PR 00936-7344
Contact: Moraima Rivera(809) 764-3083
OPEN 971103 ACTU: 5031.
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