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Completed

NCT Number: NCT00615563

Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

The primary objective of this trial was to assess the presence of susceptibility to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective was to examine clinicians' use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients that meet the following inclusion criteria will be eligible for participation in this study:

  • Signed patient informed consent prior to study participation.
  • HIV-1 infected male or female ?18 years of age.
  • Have confirmed (2 consecutive) HIV RNA ?1000 copies/mL (one of the results must be within 3 months of enrollment into the study).
  • Current HAART regimen contains a protease inhibitor for ?3 months.
  • Physicians considering a change in the patient?s HAART regimen. f.) History of treatment with 2 or more protease inhibitors (including the current PI). Low dose ritonavir (i.e.< 400 mg. bid) is not counted as one of the PIs.

Exclusion criteria

A patient with any of the following criteria will be excluded from participation in the study:

  • ARV medication naive.
  • Active opportunistic infection. c.) Known or suspected non-adherence to current HAART regimen as assessed by the investigator.

Treatment and study plan

NO BI Drug administered

Behavioral

Primary outcomes

  1. Level of sensitivity of a patient's HIV-1 isolate to tipranavir

    Time frame: Day 1

  2. Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).

    Time frame: Day 1

Secondary outcomes

  1. Protease inhibitor(s) (PI) identified by the clinician prior to resistance testing to which a patient's HIV-1 virus was thought to be susceptible

    Time frame: Day 1

  2. PI that was discontinued or initiated after receiving resistance testing results

    Time frame: up to 45 days

  3. Non-PI ARVs that were discontinued or initiated after receiving resistance testing results

    Time frame: up to 45 days

  4. Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results

    Time frame: up to 45 days

  5. Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results

    Time frame: up to 45 days

  6. Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing

    Time frame: up to 45 days

  7. The physician's assessment of whether the phenotypic testing (as part of combined testing) provided more information than the genotypic test alone did

    Time frame: up to 45 days

  8. Physician reported limitations that influence access to resistance testing

    Time frame: day 1

  9. Clinician reported reasons why tipranavir was or was not considered as an option for each patient

    Time frame: up to 45 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 14, 2008
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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