Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection

This prospective observational study will evaluate predictors of response to Invirase (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected during 48 weeks of treatment.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bialystok, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients, >/= 18 years of age
HIV infection
Treatment-naïve
Initiation of treatment with Invirase

Exclusion criteria

Contraindications according to Invirase Summary of Product Characteristics

Treatment and study plan

Primary outcomes

Predictive value of baseline CD4 count and HIV RNA on virological and immunological response at 12, 24 and 48 weeks of treatment

Time frame: 48 weeks

Secondary outcomes

Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment

Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Prospective Multicentre Noninterventional Observational Study on Predictors of Treatment Response in a Cohort of Treatment naïve HIV-infected Patients Treated With Saquinavir (PROSPECTOR)

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Feb 16, 2011
Registry last updated: Nov 2, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed