Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

HIV Infections Clinical Trial

— PALM  

Official title:

Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00981318
• Other study ID #: Rodwick01
• Status: Terminated
• Phase: Phase 4
• First received: September 19, 2009
• Last updated: June 20, 2015
• Start date: December 2009
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Rodwick, Barry M., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• lopinavir/ritonavir plus maraviroc
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Locations

Country	Name	City	State
United States	Barry M. Rodwick, M. D.	Safety Harbor	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Rodwick, Barry M., M.D.	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response defined as viral load reduction of >/= 1 log		48 weeks	No
Secondary	Assess proportion of patients with HIV-1 viral load < 48 copies		48 weks	No
Secondary	Assess time to loss of virologic response		48 weeks	No
Secondary	Assess development of resistance mutations in patients who develop rebound		48 weeks	No
Secondary	Compare serum lipid profile changes		48 weeks	No
Secondary	Assess safety and tolerability		48 weeks	Yes
Secondary	Assess degree of immune reconstitution		48 weeks	No