HIV Alert: Study Specifications

HIVAlert: Study Organization
Background data * Patient and demographic overview: patient populations, route of
seroconversion, stage of disease progress, patients on trial
* Hematologic complications and treatment
- Neutropenia, anemia, thrombocytopenia
* Diagnosis/monitoring of disease progression
- Diagnostic frequency and viral load monitoring
- Phenotypic/genotypic mapping
* Mortality and cause of death
Antiretroviral therapy * Agents deployed in combination therapy (utilizing all approved ARV
agents: AZT, 3TC, ddl, ddC, d4T, saquinavir, indinavir, nelfinavir, ritonavir,
delavirdine, nevirapine)
* Patient ARV shares by antiretroviral therapy
- Aggregate shares and shares by patient factors and physician cohort
group
- Preferred combination therapies
* Timing of therapy: initiation, change, and holding of therapy
* Salience of patient factors
* Benefits and disadvantages of major ARV drugs (efficacy, side effects,
impact on survival)
* Awareness of new agents/approaches: cell and gene therapy, new ARV
agents in development, IL-2 in immune reconstitution
* Clinical study endpoints
Opportunistic infections * Ols covered: MAC, CMV disease, fungal complications, AIDS wasting,
and others as specified by subscribers
* Prevalence and lifetime incidence
* Prophylaxis
* First-line and second-line treatments; benefits and disadvantages
Market perspectives * Sources of information for physicians
* Feedback on drug companies

Patient perspectives

Patient ARV-regimen adherence and compliance issues
Awareness of treatment history
Cost and payment issues

Figure: HIVAlert Waves Conjoint Perspectives: Physicians, Patients, and Treatment
ARV Treatment (any drug or drug class combination)
* NRTIs: AZT, 3TC, ddl, ddC, d4T
* PIs: saquinavir, indinavir, nelfinavir, ritonavir
* NNRTIs: delavirdine, nevirapine

Patient Factors (any combinable factor and level)
* Route of HIV transmission
* CD4count
* Treatment history
* Viral load test resul
* Insurance coverage

Physician Cohort (any combinable cohort)
* Physician classification: thought leaders versus general population/
community physicians
* Geography: East Coast versus West Coast versus Midwest/Southwest
* Patient volume: high (>_50 patients/week) versus low (<49 patients/week)
practice volumes
* Specialty: kifectious disease specialists and all others