PENTA Fosamprenavir Study
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ClinicalTrials.gov Identifier: NCT01077635 |
Recruitment Status
:
Completed
First Posted
: March 1, 2010
Last Update Posted
: June 1, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Infection, Human Immunodeficiency Virus | Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV) |
Study Type : | Observational |
Actual Enrollment : | 1 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An Observational Multi-cohort Study on the Use of Fosamprenavir-Ritonavir Among HIV-infected Children and Adolescents in Europe |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Group/Cohort | Intervention/treatment |
---|---|
HIV-1 infected children aged 6 ≤ 18 years
HIV-1 infected children aged 6 ≤ 18 years currently or having ever been exposed to FPV/RTV; this is the indicated group for the licensed dose in the paediatric population.
|
Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
HIV-1 infected children currently or having ever been exposed to FPV (+/- 20% of 18mg/kg BID + RTV)
|
- Number of children on licensed dose of FPV/RTV [ Time Frame: Assessed at 1, 2 and 3 years post exposure ]
- Reason for stopping FPV [ Time Frame: Assessed at 1, 2 and 3 years post exposure ]
- Laboratory tests for absolute neutrophil counts (ANC), lipids (total cholesterol [TC] and triglycerides [TG]), and alanine transaminase (ALT) [ Time Frame: Assessed at 1, 2 and 3 years post exposure ]

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- HIV-1 infected children aged 6-18 years exposed to licensed paediatric dose of FPV/RTV January 1 2008 (or date of exposure to FPV if earlier to this but still exposed at 1/1/2008) from the participating cohorts
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077635
Study Director: | GSK Clinical Trials | ViiV Healthcare |
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT01077635 History of Changes |
Other Study ID Numbers: |
112880 |
First Posted: | March 1, 2010 Key Record Dates |
Last Update Posted: | June 1, 2017 |
Last Verified: | January 2012 |
Keywords provided by ViiV Healthcare:
HIV Antiretroviral therapy protease inbitor fosamprenavir paediatrics |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Fosamprenavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |