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A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)


Phase 2
13 Years
N/A
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)


The rapid emergence of resistant HIV strains has been observed in patients receiving
monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use
of combination therapy with two nucleoside drugs or convergent combination therapy with two
nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant
HIV strains. Since toxicity is a major problem in patients with advanced disease who are
receiving combination nucleoside therapy, alternating the two drugs may provide a way of
retaining several benefits of combination therapy while minimizing the increased toxicity.

Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with
ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter
for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted.
Patients who are already enrolled on protocol ACTG 193 will be given the option of
continuing on their originally assigned ACTG 193 therapy for an additional 6 months or
undergoing re-randomization to one of the four treatment arms on ACTG 193A.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Required:

- PCP prophylaxis.

Allowed:

- Erythropoietin maintenance.

- G-CSF and GM-CSF.

- Prophylaxis for Mycobacterium avium intracellulare.

- Antifungal prophylaxis or treatment with specific drugs.

- Maintenance therapy for opportunistic infection.

- Over-the-counter medications or alternative therapies such as vitamins and herbs.

- Antibiotics as clinically indicated.

- Steroids for < 21 days for acute problems.

- Antipyretics, analgesics, allergy medication, antidepressants, sleep medications,
oral contraceptives, or other appropriate medications.

Concurrent Treatment:

Allowed:

- Radiation therapy for cutaneous Kaposi's sarcoma.

- Acupuncture.

Patients must have:

- Documented HIV infection.

- CD4 count <= 50 cells/mm3.

- Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the
absence of high-grade intolerance.

- Life expectancy of at least 6 months.

- Consent of parent or guardian if < 18 years of age.

- Normal chest x-ray at baseline or within 6 months prior to study entry in the absence
of new pulmonary or cardiac symptoms (per 12/28/94 amendment).

NOTE:

- Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A
are not eligible.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Abnormal baseline chest x-ray.

- New pulmonary or cardiac symptoms.

- Psychological or emotional problems sufficient to prevent compliance with study
medication.

Concurrent Medication:

Excluded:

- Systemic chemotherapy for malignancy.

- Acute or induction therapy for opportunistic infection.

- Antiretroviral drugs other than study drugs.

- Biological response modifiers.

- Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin.

Patients with the following prior conditions are excluded:

- History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more
occasions.

- Evidence of active pulmonary disease within 6 months prior to study entry.

- History of grade 3 or worse peripheral neuropathy.

- History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

- Prior nevirapine.

Excluded within 7 days prior to study entry:

- Acute therapy for opportunistic infection (maintenance therapy is permitted).

- Acute systemic therapy for a nonopportunistic infection or other medical condition.

- Antiretroviral drugs other than AZT, ddI, or ddC.

- Biological response modifiers.

- d4T therapy.

- Nucleosides other than those used in the study.

- Antibiotics containing clavulanate potassium.

Prior Treatment:

Excluded:

- More than 4 units of blood in a 30-day period.

Active alcohol or drug abuse.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Henry WK

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 193A

NCT ID:

NCT00000781

Start Date:

Completion Date:

September 1996

Related Keywords:

  • HIV Infections
  • Zalcitabine
  • Didanosine
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Nevirapine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, California  94115
Olive View Med CtrSylmar, California  91342
Harbor UCLA Med CtrTorrance, California  90502
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Boston Med CtrBoston, Massachusetts  02118
Univ of MinnesotaMinneapolis, Minnesota  55455
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, New York  10461
Jack Weiler Hosp / Bronx Municipal HospBronx, New York  10465
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
Montefiore Med Ctr / Bronx Municipal HospBronx, New York  10467
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
City Hosp Ctr at Elmhurst / Mount Sinai HospElmhurst, New York  11373
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
SUNY / State Univ of New YorkSyracuse, New York  13210
Univ of North CarolinaChapel Hill, North Carolina  275997215
Med College of OhioToledo, Ohio  43699
Milton S Hershey Med CtrHershey, Pennsylvania  170330850
Univ of Tennessee / E Tennessee Comprehensive Hemophilia CtrKnoxville, Tennessee  37920
Univ of WashingtonSeattle, Washington  98105
Great Lakes Hemophilia FoundationMilwaukee, Wisconsin  53233
Univ of South FloridaTampa, Florida  33612
St Louis Regional Hosp / St Louis Regional Med CtrSt Louis, Missouri  63112
Columbus Children's HospColumbus, Ohio  432052696
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Cook County HospChicago, Illinois  60612
Hennepin County Med ClinicMinneapolis, Minnesota  55415
St Paul Ramsey Med CtrSt Paul, Minnesota  55101
Univ of Nebraska Med CtrOmaha, Nebraska  681985130
Montefiore Drug Treatment Ctr / Bronx Municipal HospBronx, New York  10461
Montefiore Family Health Ctr / Bronx Municipal HospBronx, New York  10461
Samaritan Village Inc / Bronx Municipal HospBronx, New York  10461
Comprehensive Health Care Ctr / Bronx Municipal HospBronx, New York  10461
North Central Bronx Hosp / Bronx Municipal HospBronx, New York  10467
Beth Israel Med CtrNew York, New York  10003
Saint Clare's Hosp and Health CtrNew York, New York  10019
Moses H Cone Memorial HospGreensboro, North Carolina  27401
Univ of CincinnatiCincinnati, Ohio  452670405
Girard Med CtrPhiladelphia, Pennsylvania  191046073
Thomas Jefferson Univ HospPhiladelphia, Pennsylvania  191075098
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104
Children's Hosp of Los AngelesLos Angeles, California  90027
Huntington Memorial Hosp / Children's Hosp of Los AngelesPasadena, California  91105
Santa Clara Valley Med Ctr / AIDS Community Rsch ConsortiumSan Jose, California  951282699
Stanford Univ Med CtrStanford, California  943055107
San Mateo AIDS Program / Stanford UnivStanford, California  943055107
Mountain States Reg Hemo Ctr / Univ of ColoradoDenver, Colorado  80262
Denver Dept of Health and HospsDenver, Colorado  80262
Rose Med CtrDenver, Colorado  80262
Yale Univ / New HavenNew Haven, Connecticut  065102483
Howard UnivWashington, District of Columbia  20059
Georgetown Univ Med CtrWashington, District of Columbia  20007
Whitman - Walker Clinic / Georgetown Univ Med CtrWashington, District of Columbia  200072197
HIV Ctr - District of Columbia Gen HospWashington, District of Columbia  200072197
George Washington Univ / Hershey Med CtrWashington, District of Columbia  20037
Univ of HawaiiHonolulu, Hawaii  96816
Louis A Weiss Memorial HospChicago, Illinois  60640
Methodist Hosp of Indiana / Life Care ClinicIndianapolis, Indiana  46202
Univ of Louisville / East Tennesee Comprehensive Hem CtrLouisville, Kentucky  40202
Worcester Memorial Hosp / Med Ctr of Cntrl MA-MemorialWorcester, Massachusetts  01605
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl MassachusettsLebanon, New Hampshire  03756
Robert Wood Johnson Med School / Hershey Med CtrNew Brunswick, New Jersey  08903
Univ of Medicine & Dentistry of New Jersey / Univ HospNewark, New Jersey  071032714
Adirondack Med Ctr at Saranac LakeAlbany, New York  122083479
Albany Med College / Division of HIV Medicine A158Albany, New York  122083479
Mid - Hudson Care CtrAlbany, New York  122083479
Montefiore Med Ctr Adolescent AIDS ProgramBronx, New York  10467
SUNY / Health Sciences Ctr at BrooklynBrooklyn, New York  112032098
North Shore Univ HospManhasset, New York  11030
Mount Sinai Med Ctr / Hemophilia Treatment CtrNew York, New York  10029
Harlem Hosp CtrNew York, New York  10037
Columbia Presbyterian Med CtrNew York, New York  100323784
Univ of Kentucky LexingtonCincinnati, Ohio  45267
MetroHealth Med CtrCleveland, Ohio  441091998
Case Western Reserve UnivCleveland, Ohio  44106
Saint Michael's Med Ctr / Milton S Hershey Med CtrHershey, Pennsylvania  170330850
Med Univ of South Carolina / UNCCharleston, South Carolina  29425
Meharry Med CollegeNashville, Tennessee  37203
Univ of Texas GalvestonGalveston, Texas  775550435
Univ Texas Health Science Ctr / Univ Texas Med SchoolHouston, Texas  77030
Northern Wisconsin Hemophilia Ctr / Saint Vincent's HospGreen Bay, Wisconsin  54301