Completed

Phase 2
Age: 6Months - 10Years
All Genders
ID00000851

Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

198

Participants Needed

35

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden. In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

CONDITIONS

Official Title

Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Who Can Participate

Age: 6Months - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Patients must:

  • Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
  • Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
  • Have parent or legal guardian willing to sign a consent.

Prior Medication: Required:

  • On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Intractable diarrhea or vomiting.
  • Current clinical or laboratory Grade 3 or worse toxicities.

Concurrent Medication:

Excluded:

  • Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
  • Chemotherapy for active malignancy.

Patients with any of the following prior conditions are excluded:

  • Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
  • Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
  • Subjects who have had chemotherapy for active malignancy.

Prior Medication:

Excluded:

  • Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
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: 35 locations

1

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, United States, 90502

Status Unknown

2

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, United States

Status Unknown

3

Univ. of Connecticut Health Ctr., Dept. of Ped.

Farmington, Connecticut, United States, 06032

Status Unknown

4

Connecticut Children's Med. Ctr.

Hartford, Connecticut, United States

Status Unknown

5

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, United States, 20010

Status Unknown

6

Howard Univ. Washington DC NICHD CRS

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

Status Unknown

7

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, United States, 32209

Status Unknown

8

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, United States, 33161

Status Unknown

9

Cook County Hosp.

Chicago, Illinois, United States, 60612

Status Unknown

10

Chicago Children's CRS

Chicago, Illinois, United States, 60614

Status Unknown

11

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, United States, 60637

Status Unknown

12

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States, 70112

Status Unknown

13

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, United States, 21201

Status Unknown

14

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, United States, 02115

Status Unknown

15

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, United States, 48201

Status Unknown

16

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, United States, 08903

Status Unknown

17

NJ Med. School CRS

Newark, New Jersey, United States

Status Unknown

18

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, United States, 11203

Status Unknown

19

North Shore-Long Island Jewish Health System, Dept. of Peds.

Great Neck, New York, United States, 11021

Status Unknown

20

Schneider Children's Hosp., Div. of Infectious Diseases

New Hyde Park, New York, United States, 11040

Status Unknown

21

Metropolitan Hosp. NICHD CRS

New York, New York, United States, 10029

Status Unknown

22

Columbia IMPAACT CRS

New York, New York, United States, 10032

Status Unknown

23

Incarnation Children's Ctr.

New York, New York, United States, 10032

Status Unknown

24

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, United States, 10037

Status Unknown

25

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, United States

Status Unknown

26

SUNY Stony Brook NICHD CRS

Stony Brook, New York, United States

Status Unknown

27

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, United States, 10457

Status Unknown

28

DUMC Ped. CRS

Durham, North Carolina, United States, 27710

Status Unknown

29

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, United States, 19134

Status Unknown

30

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

Charleston, South Carolina, United States, 29425

Status Unknown

31

Children's Med. Ctr. Dallas

Dallas, Texas, United States, 75235

Status Unknown

32

Texas Children's Hosp. CRS

Houston, Texas, United States, 77030

Status Unknown

33

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

Bayamón, Puerto Rico, 00956

Status Unknown

34

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico, 00936

Status Unknown

35

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, Puerto Rico, 00936

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team.

M W Kline, R B Van Dyke, J C Lindsey...

https://pubmed.ncbi.nlm.nih.gov/10224206