Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Information provided by:
Rodwick, Barry M., M.D. Identifier:
First received: September 19, 2009
Last updated: February 22, 2010
Last verified: February 2010

September 19, 2009
February 22, 2010
December 2009
July 2011   (final data collection date for primary outcome measure)
Virologic response defined as viral load reduction of >/= 1 log [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00981318 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients

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.

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.

Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
Drug: lopinavir/ritonavir plus maraviroc
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Other Names:
  • Kaletra
  • lopinavir
  • Selzentry
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
July 2011   (final data collection date for primary outcome measure)

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
18 Years and older
Contact: Barry M. Rodwick, M. D. 727-725-9931
Contact: Tiffany D. Ross, MA CRC 727-725-9931
United States
Barry M. Rodwick, M. D.
Rodwick, Barry M., M.D.
Principal Investigator: Barry M. Rodwick, M. D. Barry M. Rodwick, M. D.
Rodwick, Barry M., M.D.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP