Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)
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ClinicalTrials.gov Identifier: NCT00981318 |
Recruitment Status
:
Terminated
(unable to enroll expected number of subjects)
First Posted
: September 22, 2009
Last Update Posted
: June 23, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Acquired Immunodeficiency Syndrome | Drug: lopinavir/ritonavir plus maraviroc | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
single arm
|
Drug: lopinavir/ritonavir plus maraviroc
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Other Names:
|
- Virologic response defined as viral load reduction of >/= 1 log [ Time Frame: 48 weeks ]
- Assess proportion of patients with HIV-1 viral load < 48 copies [ Time Frame: 48 weks ]
- Assess time to loss of virologic response [ Time Frame: 48 weeks ]
- Assess development of resistance mutations in patients who develop rebound [ Time Frame: 48 weeks ]
- Compare serum lipid profile changes [ Time Frame: 48 weeks ]
- Assess safety and tolerability [ Time Frame: 48 weeks ]
- Assess degree of immune reconstitution [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00981318
United States, Florida | |
Barry M. Rodwick, M. D. | |
Safety Harbor, Florida, United States, 34695 |
Principal Investigator: | Barry M. Rodwick, M. D. | Barry M. Rodwick, M. D. |
Responsible Party: | Barry M. Rodwick, M. D., Principal Investigator, Rodwick, Barry M., M.D. |
ClinicalTrials.gov Identifier: | NCT00981318 History of Changes |
Other Study ID Numbers: |
Rodwick01 |
First Posted: | September 22, 2009 Key Record Dates |
Last Update Posted: | June 23, 2015 |
Last Verified: | June 2015 |
Keywords provided by Barry M. Rodwick, M. D., Rodwick, Barry M., M.D.:
Acquired Immunodeficiency Syndrome HIV AIDS treatment experienced |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir |
Maraviroc HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors CCR5 Receptor Antagonists |