|
STAR Adult Studies
|
| Study Type |
Phase |
Study Name |
Description |
Entry Criteria |
Other Criteria |
|
|
|
|
CD4 |
Viral Load |
|
Experienced
and Virologically Failing
|
|
HIV Resistance Study
The Resistance Study: An Evaluation of the Relative Clinical Value of Genotypic and Phenotypic Antiretroviral Resistance Testing for Patients who are Failing Antiretroviral Therapy
|
Study II - HIV resistance profiles in treatment experienced patients. Difference in prescribing practices based on genotypic versus phenotypic profiles. |
|
>1000 |
On ART with increasing viral load suggestive of either emergence of resistant virus, or failure to suppress replicating drug-sensitive virus.
On stable ART for > 16 weeks
|
1st Failure containing
NNRTI
|
III |
BMS AI424103
A Phase IIIB, Open-Label, Randomized, Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, each in Combination with Tenofovir and either Didanosine EC (ddI EC) or Stavudine XR (d4T XR) in HIV-1 Infected Subjects Receiving a NNRTI-Containing HAART Regimen who are Experiencing their First Virologic Failure
|
Open-label Randomized study comparing Atazanvir to Atazanvir/Ritonavir + TFV and ddI EC or STV XR (84 wks) |
>50 |
>1000 |
Either remains on failing NNRT-regimen or untreated since failure prior to initiating study. |
|
II |
Capravirine (A4311006)
A Phase 2, Randomized, Double-Blind, Dose-Ranging Study of Capravirine (AG1549) in Combination with Kaletra and at least 2 Nucleoside Reverse Transcriptase Inhibitors in HIV-infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors
|
Capravirine with Kaletra and 2 NRTIs in patients who have failed NNRTI and at least 1 but no more than 3 PI containing regimens (48 wks) |
>50 |
>1000 |
No prior Kaletra or Capravirine experience. RTV adjuvant as part of prior PI experience OK. |
Experienced
and Virologically Suppressed
|
IV |
VEST-QD
BMS AI266-406 VEST-QD: A Phase IV, Open-Label, Randomized, Multicenter Study Switching HIV-1 Infected Subjects with a Viral Load <50 Copies/mL on a First PI-Based Regimen to an Efavirenz Substitution Regimen
|
Open-Label, Randomized, Switching Study from 1st PI-based regimen to Efavirenz Substitution Regimen (48 wks) |
|
>50 |
|
|
III |
BMS AI424100
A Phase IIIB, Open-label, Randomized, Multicenter Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir/Ritonavir in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a Lopinavir/Ritonavir Based Regimen
|
Open-label, Randomized Switching study from Kaletra based regimen to Atazanvir/Ritonavir (48 wks) |
|
>50 |
LDL >130 mg/dL |
ARV Naïve and Acute HIV Infection
|
|
AIEDRP (AI 41534)
Acute Infection and Early Disease Research
Program (AIEDRP)
|
Observational study of treated and untreated acute and early HIV infection |
|
|
Pos HIV antibody test and S&S of acute viremia. Long term follow-up (5 years) |
ARV Treatment Options
|
|
SMART (CPCRA 065)
A Large, Simple Trial Comparing Two Strategies For Management of Anti-retroviral Therapy
|
Randomized comparison of drug conservation (STI) versus viral suppression strategy |
>350 |
|
Willingness to randomize to either treatment arm. Commitment to long term (up to 9 yrs) follow-up. |
