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NCT00001045

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

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1998-10-31

Brief Summary

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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.

Detailed Description

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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

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HIV Infections

Keywords

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Didanosine Drug Therapy, Combination Zidovudine Nevirapine

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nevirapine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merigan TC

Role: STUDY_CHAIR

Mayers DL

Role: STUDY_CHAIR

Locations

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UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States

Site Status

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States

Site Status

Stanford Univ Med Ctr

Stanford, California, United States

Site Status

Harbor UCLA Med Ctr

Torrance, California, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status

Georgetown Univ Med Ctr

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

Site Status

Children's Hosp of Washington DC

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

Site Status

George Washington Univ / Hershey Med Ctr

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

Site Status

Walter Reed Army Med Ctr

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

Site Status

Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States

Site Status

Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, United States

Site Status

Queens Med Ctr

Honolulu, Hawaii, United States

Site Status

Univ of Hawaii

Honolulu, Hawaii, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Univ of Iowa Hosp and Clinic

Iowa City, Iowa, United States

Site Status

State of MD Div of Corrections / Johns Hopkins Univ Hosp

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Natl Naval Med Ctr

Bethesda, Maryland, United States

Site Status

Fitzsimmons Army Med Ctr

Rockville, Maryland, United States

Site Status

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Site Status

Hennepin County Med Clinic

Minneapolis, Minnesota, United States

Site Status

Univ of Minnesota

Minneapolis, Minnesota, United States

Site Status

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, United States

Site Status

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States

Site Status

Adirondack Med Ctr at Saranac Lake

Albany, New York, United States

Site Status

Albany Med College / Division of HIV Medicine A158

Albany, New York, United States

Site Status

Mid - Hudson Care Ctr

Albany, New York, United States

Site Status

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States

Site Status

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Site Status

Columbia Presbyterian Med Ctr

New York, New York, United States

Site Status

Harlem Hosp Ctr

New York, New York, United States

Site Status

Univ of Rochester Medical Center

Rochester, New York, United States

Site Status