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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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A single center, open label, 48-week study of lopinavir/ritonavir in combination with raltegravir. 30 patients, both naïve and experienced, will be enrolled. 15 treatment naïve patients and 15 treatment experienced patients enrolled
This is an open-labeled, non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria. This study will assess the impact of lopinavir/ritonavir in combination with raltegravir on HIV-1
Patients will be evaluated frequently over the 52 weeks of the protocol. Patients will be seen at screening, baseline, week 4, 12, 24, 36, 48, and 52, to include physical examination, assessment for the development of AIDS-defining conditions, hematology, chemistry, lipid profile, CD4, CD8 cell counts, plasma HIV-1 RNA ultrasensitive, and assessment of adverse events. If HIV-1 RNA becomes detectable, this will be repeated for confirmation with 2 weeks. HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of > 1,000 copies/mL.
An interim analysis will be performed when all patients have reached the week 24 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | open label single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lopinavir/ritonavir and raltegravir | Drug | lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this trial is to evaluate the percentage of patients with HIV-1 RNA below 50 copies at week 48 receiving lopinavir/ritonavir in combination with raltegravir | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of lopinavir/ritonavir in combination with raltegravir in maintaining virological suppression | weeks 12, 24, 36, and 48 | |
| To evaluate the change from baseline in plasma HIV-1 RNA at weeks 12, 24, 36, and 48 | weeks 12, 24, 36, and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihad Slim, MD | Saint Michael's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2012 | |
| Reset | Jan 22, 2013 | |
| Release | Aug 3, 2016 | |
| Reset | Sep 23, 2016 | |
| Release | Mar 28, 2021 | |
| Reset | Mar 29, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2012 | Jan 22, 2013 | |||
| Aug 3, 2016 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| D000068898 | Raltegravir Potassium |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sep 23, 2016 |
| Mar 28, 2021 | Mar 29, 2021 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |