Completed

Phase 1
Age: 6Months - 20Years
All Genders
ID00000814

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28

390

Participants Needed

68

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

CONDITIONS

Official Title

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Who Can Participate

Age: 6Months - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Erythropoietin.

Concurrent Treatment:

Allowed:

  • Transfusion.

Patients must have:

  • Progressive HIV disease.
  • At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active malignancy requiring chemotherapy.
  • Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
  • Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.

Concurrent Medication:

Excluded (unless exemption made by study chair):

  • Oral anticoagulants (warfarin, dicumarol).
  • Oral contraceptives.
  • Digitalis glycosides.
  • Phenytoin.
  • Theophylline.

Patients with the following prior conditions are excluded:

  • History of clinical pancreatitis.
  • History of grade 2 or worse peripheral neuropathy.

Prior Treatment:

Excluded:

  • Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 68 locations

1

Univ of Alabama at Birmingham Schl of Med / Pediatrics

Birmingham, Alabama, United States, 35294

Status Unknown

2

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States, 920930672

Status Unknown

3

Long Beach Memorial (Pediatric)

Long Beach, California, United States, 90801

Status Unknown

4

Los Angeles County - USC Med Ctr

Los Angeles, California, United States, 90033

Status Unknown

5

Cedars Sinai / UCLA Med Ctr

Los Angeles, California, United States, 900481804

Status Unknown

6

UCLA Med Ctr / Pediatric

Los Angeles, California, United States, 900951752

Status Unknown

7

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, United States, 905022004

Status Unknown

8

Children's Hosp of Oakland

Oakland, California, United States, 946091809

Status Unknown

9

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, United States, 941430105

Status Unknown

10

Children's Hosp of Denver

Denver, Colorado, United States, 802181088

Status Unknown

11

Univ of Connecticut / Farmington

Farmington, Connecticut, United States, 06032

Status Unknown

12

Yale Univ Med School

New Haven, Connecticut, United States, 06504

Status Unknown

13

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States, 200072197

Status Unknown

14

Children's Hosp of Washington DC

Washington D.C., District of Columbia, United States, 200102916

Status Unknown

15

Howard Univ Hosp

Washington D.C., District of Columbia, United States, 20060

Status Unknown

16

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States, 32209

Status Unknown

17

Univ of Miami (Pediatric)

Miami, Florida, United States, 33161

Status Unknown

18

Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States, 30306

Status Unknown

19

Cook County Hosp

Chicago, Illinois, United States, 60612

Status Unknown

20

Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, United States, 60612

Status Unknown

21

Chicago Children's Memorial Hosp

Chicago, Illinois, United States, 606143394

Status Unknown

22

Univ of Chicago Children's Hosp

Chicago, Illinois, United States, 606371470

Status Unknown

23

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, United States, 701122699

Status Unknown

24

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, United States, 21201

Status Unknown

25

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, United States, 212874933

Status Unknown

26

Children's Hosp of Boston

Boston, Massachusetts, United States, 021155724

Status Unknown

27

Baystate Med Ctr of Springfield

Springfield, Massachusetts, United States, 01199

Status Unknown

28

Univ of Massachusetts Med School

Worcester, Massachusetts, United States, 016550001

Status Unknown

29

Children's Hosp of Michigan

Detroit, Michigan, United States, 48201

Status Unknown

30

UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, United States, 089030019

Status Unknown

31

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

Newark, New Jersey, United States, 07103

Status Unknown

32

Children's Hosp at Albany Med Ctr

Albany, New York, United States, 12208

Status Unknown

33

King's County Hosp Ctr / Pediatrics

Brooklyn, New York, United States, 11203

Status Unknown

34

SUNY - Brooklyn

Brooklyn, New York, United States, 11203

Status Unknown

35

North Shore Univ Hosp

Great Neck, New York, United States, 11021

Status Unknown

36

Schneider Children's Hosp

New Hyde Park, New York, United States, 11040

Status Unknown

37

Beth Israel Med Ctr / Pediatrics

New York, New York, United States, 10003

Status Unknown

38

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

39

Cornell Univ Med College

New York, New York, United States, 10021

Status Unknown

40

Metropolitan Hosp Ctr

New York, New York, United States, 10029

Status Unknown

41

Mount Sinai Med Ctr / Hemophilia Treatment Ctr

New York, New York, United States, 10029

Status Unknown

42

Mount Sinai Med Ctr / Pediatrics

New York, New York, United States, 10029

Status Unknown

43

Columbia Presbyterian Med Ctr

New York, New York, United States, 10032

Status Unknown

44

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

New York, New York, United States, 10032

Status Unknown

45

Harlem Hosp Ctr

New York, New York, United States, 10037

Status Unknown

46

Univ of Rochester Medical Center

Rochester, New York, United States, 14642

Status Unknown

47

State Univ of New York at Stony Brook

Stony Brook, New York, United States, 117948111

Status Unknown

48

SUNY Health Sciences Ctr at Syracuse / Pediatrics

Syracuse, New York, United States, 13210

Status Unknown

49

Bronx Lebanon Hosp Ctr

The Bronx, New York, United States, 10457

Status Unknown

50

Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr

The Bronx, New York, United States, 10461

Status Unknown

51

Westchester Hosp

Valhalla, New York, United States, 10595

Status Unknown

52

Duke Univ Med Ctr

Durham, North Carolina, United States, 277103499

Status Unknown

53

Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

Durham, North Carolina, United States, 27710

Status Unknown

54

Columbus Children's Hosp

Columbus, Ohio, United States, 432052696

Status Unknown

55

West Central Ohio Hemophilia Ctr / Children's Med Ctr

Dayton, Ohio, United States, 454041815

Status Unknown

56

Milton S Hershey Med Ctr

Hershey, Pennsylvania, United States, 170330850

Status Unknown

57

Univ of Pittsburgh Med School / Hershey Med Ctr

Hershey, Pennsylvania, United States, 170330850

Status Unknown

58

Children's Hosp of Philadelphia

Philadelphia, Pennsylvania, United States, 191044318

Status Unknown

59

Saint Christopher's Hosp for Children

Philadelphia, Pennsylvania, United States, 191341095

Status Unknown

60

Rhode Island Hosp / Brown Univ

Providence, Rhode Island, United States, 02903

Status Unknown

61

Med Univ of South Carolina

Charleston, South Carolina, United States, 294253312

Status Unknown

62

Children's Med Ctr of Dallas

Dallas, Texas, United States, 75235

Status Unknown

63

Texas Children's Hosp / Baylor Univ

Houston, Texas, United States, 77030

Status Unknown

64

Children's Hosp of the King's Daughters

Norfolk, Virginia, United States, 23507

Status Unknown

65

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, United States, 981050371

Status Unknown

66

Ramon Ruiz Arnau Univ Hosp / Pediatrics

Bayamón, Puerto Rico, 00956

Status Unknown

67

Univ of Puerto Rico / Univ Children's Hosp AIDS

San Juan, Puerto Rico, 009365067

Status Unknown

68

San Juan City Hosp

San Juan, Puerto Rico, 009367344

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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