Trial record 10 of 33 for:
" July 02, 2008":" August 01, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Study of Raltegravir Versus Nucleotide Reverse Transcriptase Inhibitors (NRTIs) as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted Protease Inhibitor (PI) Regimen
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by St. Joseph's Hospital, Florida.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
St. Joseph's Hospital, Florida
Information provided by:
St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:
NCT00717964
First received: July 16, 2008
Last updated: June 15, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary purpose of this research study is to evaluate the safety and tolerability of raltegravir 400 mg taken twice a day compared to an NRTI (nucleotide reverse transcriptase inhibitor) backbone, each with a PI (protease inhibitor) boosted with ritonavir based medication regimen, in HIV-1 positive patients. NRTI and PI are two of the categories of medications currently being used to treat HIV.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Raltegravir Drug: current antiretroviral regimen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir Versus NRTIs as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted PI Regimen |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by St. Joseph's Hospital, Florida:
Primary Outcome Measures:
- eval safety & toler. of raltegravir vs NRTI, ea w/ PI/r regimen by review of accumulated safety data eval antiretroviral activity of raltegravir ver NRTI backbone, ea w/ PI/r regimen measured by proportion of subjects w/viral load <75 copies/mL. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- eval safety & tolerability of raltegravir vs NRTI ea w/ PI/r regimen, assessed by review of accumulated safety data eval antiretroviral activity of raltegravir ver NRTI ea w/ PI/r regimen measured by proportion of subjects with viral load <75 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 34 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Raltegravir 400 mg BID with current boosted PI regimen
|
Drug: Raltegravir
400 mg po BID
Other Name: Isentress
|
| Active Comparator: 2 |
Drug: current antiretroviral regimen
remain on current antiretroviral regimen
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- documented HIV RNA <75 copies/mL
- no history of documented coronary artery disease
- Subject with Hepatitis C co-infection may be enrolled provided the subjects are stable and meet all eligibility criteria.
- no clinical evidence of active pulmonary disease
- agrees to use an acceptable method of birth control throughout the study.
Exclusion Criteria:
- currently failing a boosted PI based regimen.
- receiving a second line boosted PI regimen including boosted tipranavir or boosted darunavir.
- chronic hepatitis B infection.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717964
Locations
| United States, Florida | |
| St Joseph's Comprehensive Research Institute | |
| Tampa, Florida, United States, 33614 | |
Sponsors and Collaborators
St. Joseph's Hospital, Florida
Investigators
| Principal Investigator: | Cynthia A Mayer, DO | St Joseph's Comprehensive Research Institute |
More Information
No publications provided
| Responsible Party: | Cynthia A. Mayer, DO, St Joseph's Comprehensive Research Institute |
| ClinicalTrials.gov Identifier: | NCT00717964 History of Changes |
| Other Study ID Numbers: | IIS-CRI-01 |
| Study First Received: | July 16, 2008 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Joseph's Hospital, Florida:
|
male and female 18 or older years of age Treatment experienced on stable therapy HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013