NEW DRUG DEVELOPMENT (ANTI RETROVIRAL HIV) NONCLINICAL STUDIES

NONCLINICAL STUDIES Cell culture studies can provide useful information for the design of in vivo studies and may be predictive of the development of resistant viruses in vivo. This section identifies studies relevant to drug resistance issues in the development of antiretroviral drugs for the treatment of HIV infection.
Sponsors should complete nonclinical studies (i.e., mechanism of action, antiviral activity in cell culture, cytotoxicity and therapeutic index, and effects of serum protein binding on antiviral activity) before the initiation of phase 1 clinical studies. Cell culture drug combination activity studies for drugs that are used in clinical trials should be completed before initiation of those trials. Selection of resistant HIV-1 variants in cell culture, the phenotypic and genotypic characterization of resistance viruses, and cross-resistance analyses should be examined before initiation of clinical studies in HIV-infected patients. We recommend sponsors be consistent in the assay used for any particular analysis or measurement in phase 3 studies. Sponsors should provide data supporting the implementation and use of the new or improved assays that become available during drug development.


Source:

Drug Resistance Assay and Antiretroviral drug development guidance--->
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071173.pdf

IV. NONCLINICAL STUDIES
A. Mechanism of Action
B. Antiviral Activity in Cell Culture
C. Cytotoxicity and Therapeutic Indexes
D. Protein Binding
E. Selection of Drug-Resistant HIV-1 Variants in Cell Culture
1. Genotype
2. Phenotype
F. Cross-Resistance
G. Characterization of Genotypic and Phenotypic Assays
1. Genotypic Assays
2. Phenotypic Assays
V. CLINICAL STUDIES: USE OF RESISTANCE TESTING IN CLINICAL PHASES OF DRUG DEVELOPMENT
A. General Considerations
B. Data Collection
C. Methods and Types of Analyses
1. Baseline Genotype and Virologic Response
2. Development of HIV Mutations
3. Baseline Phenotype and Virologic Response
4. Genotypic and Phenotypic Correlations: Changes in Susceptibility from Baseline
5. Cross-Resistance
6. Additional Analyses
D. Other Considerations
1. Role for Supporting Initial Activity and Dose-Finding Studies
2. Data Collection from Dose-Finding Trials
3. Use of Resistance Data to Establish an Indication
4. Use of Resistance Data for Study Enrollment Criteria, Background Regimen Selection, and Stratification Factors
5. Nonclade B Subtypes
E. Monitoring during Phase 4

REGULATORY REQUIREMENTS FOR SUBMITTING HIV RESISTANCE DATA


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Last updated : 28-Oct 2010