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AzTrials

HIV InfectionsPhase 2NCT00001045

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

A Phase 2 study testing Nevirapine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Nevirapine, Zidovudine and Didanosine
How many people
300 participants
Where
59 sitesin 2 countries
Study dates
Start not givento Oct 1998
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 19Show fewer
  • 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.

Who cannot join

  • 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:
Show all 28Show fewer
  • 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.

Trial locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States57 sites

  • Adirondack Med Ctr at Saranac Lake

    Albany, New York, 122083479

  • Albany Med College / Division of HIV Medicine A158

    Albany, New York, 122083479

  • Mid - Hudson Care Ctr

    Albany, New York, 122083479

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia, 30306

  • Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

    Atlanta, Georgia, 303652225

  • State of MD Div of Corrections / Johns Hopkins Univ Hosp

    Baltimore, Maryland, 212052196

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Natl Naval Med Ctr

    Bethesda, Maryland, 208995000

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28203

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • MetroHealth Med Ctr

    Cleveland, Ohio, 441091998

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Univ of Texas Galveston

    Galveston, Texas, 775550435

  • Milton S Hershey Med Ctr

    Hershey, Pennsylvania, 170330850

  • Queens Med Ctr

    Honolulu, Hawaii, 96816

  • Univ of Hawaii

    Honolulu, Hawaii, 96816

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Univ of Iowa Hosp and Clinic

    Iowa City, Iowa, 52242

  • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

    Knoxville, Tennessee, 37920

  • Wilford Hall Med Ctr

    Lackland Air Force Base, Texas, 782365300

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Hennepin County Med Clinic

    Minneapolis, Minnesota, 55415

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37203

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Columbia Presbyterian Med Ctr

    New York, New York, 100323784

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Univ of Nebraska Med Ctr

    Omaha, Nebraska, 681985130

  • Univ of Pennsylvania at Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson Univ Hosp

    Philadelphia, Pennsylvania, 191075098

  • Wake County Dept of Health

    Raleigh, North Carolina, 27610

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Fitzsimmons Army Med Ctr

    Rockville, Maryland, 20850

  • St Paul Ramsey Med Ctr

    Saint Paul, Minnesota, 55101

  • Brooke Army Med Ctr

    San Antonio, Texas, 78284

  • Stanford at Kaiser / Kaiser Permanente Med Ctr

    San Francisco, California, 94115

  • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

    San Jose, California, 951282699

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California, 943055107

  • Stanford Univ Med Ctr

    Stanford, California, 943055107

  • SUNY / State Univ of New York

    Syracuse, New York, 13210

  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr

    The Bronx, New York, 10461

  • Comprehensive Health Care Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10461

  • Montefiore Family Health Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10461

  • Jack Weiler Hosp / Bronx Municipal Hosp

    The Bronx, New York, 10465

  • Montefiore Med Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10467

  • Montefiore Med Ctr Adolescent AIDS Program

    The Bronx, New York, 10467

  • North Central Bronx Hosp / Bronx Municipal Hosp

    The Bronx, New York, 10467

  • Med College of Ohio

    Toledo, Ohio, 43699

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • Georgetown Univ Med Ctr

    Washington D.C., District of Columbia, 20007

  • Children's Hosp of Washington DC

    Washington D.C., District of Columbia, 200102916

  • George Washington Univ / Hershey Med Ctr

    Washington D.C., District of Columbia, 20037

  • Walter Reed Army Med Ctr

    Washington D.C., District of Columbia, 20307

Other trials in United States

Puerto Rico2 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read the detailed description

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.

Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 years.

AS PER AMENDMENT 5/9/96: All AZT monotherapy options have been eliminated. Patients will be randomized to either Arm II or Arm III, regardless of their codon 215 status. All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III. All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment.

Conditions
HIV Infections
Being tested
Nevirapine, Zidovudine, Didanosine
Keywords
Didanosine, Drug Therapy, Combination, Zidovudine, Nevirapine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionOct 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001045
Sponsor's protocol ID
ACTG 244
Other IDs
11221
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Slade DE, Vavro CL, Stapleton JT, Swack N, StClair MH. A novel mutation at codon 215 of HIV RT. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0625)

  • Mayers D, Merigan T, Gilbert P. T215Y/F mutation associated with zidovudine (ZDV) resistance leads to poor response to ZDV+ddI or ZDV+ddI+NVP: ACTG244/RV79. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:91 (abstract no 129)

  • Holodniy M, Katzenstein D, Mole L, Winters M, Merigan T. Human immunodeficiency virus reverse transcriptase codon 215 mutations diminish virologic response to didanosine-zidovudine therapy in subjects with non-syncytium-inducing phenotype. J Infect Dis. 1996 Oct;174(4):854-7. doi: 10.1093/infdis/174.4.854.

    PubMed 8843229

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nevirapine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001045, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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