Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Rodwick, Barry M., M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Rodwick, Barry M., M.D.
Collaborator:
Abbott
Information provided by:
Rodwick, Barry M., M.D.
ClinicalTrials.gov Identifier:
NCT00981318
First received: September 19, 2009
Last updated: February 22, 2010
Last verified: February 2010
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Purpose
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Acquired Immunodeficiency Syndrome |
Drug: lopinavir/ritonavir plus maraviroc |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients |
Resource links provided by NLM:
Further study details as provided by Rodwick, Barry M., M.D.:
Primary Outcome Measures:
- Virologic response defined as viral load reduction of >/= 1 log [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess proportion of patients with HIV-1 viral load < 48 copies [ Time Frame: 48 weks ] [ Designated as safety issue: No ]
- Assess time to loss of virologic response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Assess development of resistance mutations in patients who develop rebound [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Compare serum lipid profile changes [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Assess safety and tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Assess degree of immune reconstitution [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: lopinavir/ritonavir plus maraviroc
- Kaletra
- lopinavir
- Selzentry
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Other Names:
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV viral load > 1,000 on current antiviral medications
- No resistance to study medications
- Over 18 years of age
Exclusion Criteria:
- Hepatitis B co-infection
- Pregnancy
- Previous therapy with either of the study medications
- Ongoing substance abuse
- Significant history of other physical disease
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981318
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981318
Contacts
| Contact: Barry M. Rodwick, M. D. | 727-725-9931 | Doc@DrRodwick.com | |
| Contact: Tiffany D. Ross, MA CRC | 727-725-9931 | Tiffany@DrRodwick.com |
Locations
| United States, Florida | |
| Barry M. Rodwick, M. D. | Not yet recruiting |
| Safety Harbor, Florida, United States, 34695 | |
| Contact: Tiffany D. Ross, MA CRC 727-725-9931 Tiffany@DrRodwick.com | |
| Contact: Donna Bulmer 727-725-9931 Donna@DrRodwick.com | |
| Principal Investigator: Barry M. Rodwick, M. D. | |
| Barry M. Rodwick, M. D. | Recruiting |
| Safety Harbor, Florida, United States, 34695 | |
| Contact: Barry M Rodwick, M. D. 727-725-8831 Doc@DrRodwick.com | |
| Contact: Tiffany D Ros, CRC 727-725-9931 Tiffany@DrRodwick.com | |
Sponsors and Collaborators
Rodwick, Barry M., M.D.
Abbott
Investigators
| Principal Investigator: | Barry M. Rodwick, M. D. | Barry M. Rodwick, M. D. |
More Information
No publications provided
| Responsible Party: | Barry M. Rodwick, M. D. |
| ClinicalTrials.gov Identifier: | NCT00981318 History of Changes |
| Other Study ID Numbers: | Rodwick01 |
| Study First Received: | September 19, 2009 |
| Last Updated: | February 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rodwick, Barry M., M.D.:
|
Acquired Immunodeficiency Syndrome HIV AIDS treatment experienced |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Lopinavir |
Ritonavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015