Completed

Phase 2
Age: 13Years +
All Genders
ID00001045

A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA

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

300

Participants Needed

59

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

B

Bristol-Myers Squibb

Collaborating Sponsor

AI-Summary

What this Trial Is About

To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To obtain further data on the safety and immunologic and virologic response to AZT/didanosine/nevirapine. Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.

CONDITIONS

Official Title

Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Antibiotics, antifungals, and antiviral medications, as clinically indicated.
  • Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider.

Concurrent Treatment:

Allowed:

  • Limited localized radiation therapy to the skin.

Prior Medication: Required:

  • AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry.

Patients must have:

  • Asymptomatic HIV infection.
  • CD4 count 300-600 cells/mm3.
  • No plasma/serum PCR for codon 215 mutation at screening.
  • Prior AZT monotherapy.

NOTE:

  • All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged.

AS PER AMENDMENT 04/03/95:

  • DOD female patients must have a negative pregnancy test within 48 hours prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Symptomatic grade 2 or worse peripheral neuropathy.
  • Unable to swallow capsules and tablets.
  • Other medical condition that contraindicates study participation.

Concurrent Medication:

Excluded:

  • Systemic cytotoxic chemotherapy.
  • Biologic response modifiers (such as interferon, ampligen, or PEG-IL2).
  • Anti-HIV agents other than study drugs.
  • Other investigational agents.
  • Foscarnet unless clinically indicated for unresponsive herpes virus infection.
  • Chronic antacid or H-2 blocker use.
  • Rifampin or rifamycin class agents.
  • Antibiotics containing clavulanic acid.

Concurrent Treatment:

Excluded:

  • Radiation therapy other than limited localized therapy to skin.

Patients with the following prior condition are excluded:

  • History of pancreatitis.

Prior Medication:

Excluded:

  • Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT.
  • Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening.

Prior Treatment:

Excluded:

  • Blood transfusion within the preceding 2 weeks.

Illicit drug or alcohol abuse.

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: 59 locations

1

UCLA CARE Ctr

Los Angeles, California, United States, 90095

Status Unknown

2

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States, 94115

Status Unknown

3

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States, 951282699

Status Unknown

4

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States, 943055107

Status Unknown

5

Stanford Univ Med Ctr

Stanford, California, United States, 943055107

Status Unknown

6

Harbor UCLA Med Ctr

Torrance, California, United States, 90502

Status Unknown

7

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States, 80262

Status Unknown

8

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States, 20007

Status Unknown

9

Children's Hosp of Washington DC

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

Status Unknown

10

George Washington Univ / Hershey Med Ctr

Washington D.C., District of Columbia, United States, 20037

Status Unknown

11

Walter Reed Army Med Ctr

Washington D.C., District of Columbia, United States, 20307

Status Unknown

12

Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States, 30306

Status Unknown

13

Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, United States, 303652225

Status Unknown

14

Queens Med Ctr

Honolulu, Hawaii, United States, 96816

Status Unknown

15

Univ of Hawaii

Honolulu, Hawaii, United States, 96816

Status Unknown

16

Indiana Univ Hosp

Indianapolis, Indiana, United States, 462025250

Status Unknown

17

Univ of Iowa Hosp and Clinic

Iowa City, Iowa, United States, 52242

Status Unknown

18

State of MD Div of Corrections / Johns Hopkins Univ Hosp

Baltimore, Maryland, United States, 212052196

Status Unknown

19

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287

Status Unknown

20

Natl Naval Med Ctr

Bethesda, Maryland, United States, 208995000

Status Unknown

21

Fitzsimmons Army Med Ctr

Rockville, Maryland, United States, 20850

Status Unknown

22

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States, 02215

Status Unknown

23

Hennepin County Med Clinic

Minneapolis, Minnesota, United States, 55415

Status Unknown

24

Univ of Minnesota

Minneapolis, Minnesota, United States, 55455

Status Unknown

25

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, United States, 55101

Status Unknown

26

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States, 681985130

Status Unknown

27

Adirondack Med Ctr at Saranac Lake

Albany, New York, United States, 122083479

Status Unknown

28

Albany Med College / Division of HIV Medicine A158

Albany, New York, United States, 122083479

Status Unknown

29

Mid - Hudson Care Ctr

Albany, New York, United States, 122083479

Status Unknown

30

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States, 14215

Status Unknown

31

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

32

Columbia Presbyterian Med Ctr

New York, New York, United States, 100323784

Status Unknown

33

Harlem Hosp Ctr

New York, New York, United States, 10037

Status Unknown

34

Univ of Rochester Medical Center

Rochester, New York, United States, 14642

Status Unknown

35

SUNY / State Univ of New York

Syracuse, New York, United States, 13210

Status Unknown

36

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, United States, 10461

Status Unknown

37

Comprehensive Health Care Ctr / Bronx Municipal Hosp

The Bronx, New York, United States, 10461

Status Unknown

38

Montefiore Family Health Ctr / Bronx Municipal Hosp

The Bronx, New York, United States, 10461

Status Unknown

39

Jack Weiler Hosp / Bronx Municipal Hosp

The Bronx, New York, United States, 10465

Status Unknown

40

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, United States, 10467

Status Unknown

41

Montefiore Med Ctr Adolescent AIDS Program

The Bronx, New York, United States, 10467

Status Unknown

42

North Central Bronx Hosp / Bronx Municipal Hosp

The Bronx, New York, United States, 10467

Status Unknown

43

Univ of North Carolina

Chapel Hill, North Carolina, United States, 275997215

Status Unknown

44

Carolinas Med Ctr

Charlotte, North Carolina, United States, 28203

Status Unknown

45

Wake County Dept of Health

Raleigh, North Carolina, United States, 27610

Status Unknown

46

Case Western Reserve Univ

Cleveland, Ohio, United States, 44106

Status Unknown

47

MetroHealth Med Ctr

Cleveland, Ohio, United States, 441091998

Status Unknown

48

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States, 432101228

Status Unknown

49

Med College of Ohio

Toledo, Ohio, United States, 43699

Status Unknown

50

Milton S Hershey Med Ctr

Hershey, Pennsylvania, United States, 170330850

Status Unknown

51

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

52

Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, United States, 191075098

Status Unknown

53

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

Knoxville, Tennessee, United States, 37920

Status Unknown

54

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States, 37203

Status Unknown

55

Univ of Texas Galveston

Galveston, Texas, United States, 775550435

Status Unknown

56

Wilford Hall Med Ctr

Lackland Air Force Base, Texas, United States, 782365300

Status Unknown

57

Brooke Army Med Ctr

San Antonio, Texas, United States, 78284

Status Unknown

58

Ramon Ruiz Arnau Univ Hosp / Pediatrics

Bayamón, Puerto Rico, 00956

Status Unknown

59

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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Published Research Related To This Trial

Human immunodeficiency virus reverse transcriptase codon 215 mutations diminish virologic response to didanosine-zidovudine therapy in subjects with non-syncytium-inducing phenotype.

M Holodniy, D Katzenstein, L Mole...

https://pubmed.ncbi.nlm.nih.gov/8843229