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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001045 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine Drug: Zidovudine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 300 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Prior Medication: Required:
Patients must have:
NOTE:
AS PER AMENDMENT 04/03/95:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Illicit drug or alcohol abuse.
Contacts and Locations
Show 59 Study Locations| Study Chair: | Merigan TC | |
| Study Chair: | Mayers DL |
More Information
| Study ID Numbers: | ACTG 244 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001045 History of Changes |
| Health Authority: | United States: Federal Government |
|
Didanosine Drug Therapy, Combination Zidovudine Nevirapine |
|
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Nevirapine Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |