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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Tibotec, Inc | INDUSTRY |
| BluKyne | UNKNOWN |
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The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kaletra And Intelence | Experimental | This is a Phase IV, 48-week, open-label, pilot study in 30 ARV-naïve patients examining the safety, viral response, and tolerability of Kaletra® and Intelence™ tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kaletra and Intelence Tablets | Drug | Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48 | At weeks 24 and 48 | |
| Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48 | At weeks 24 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit | At weeks 24 and 48 | |
| Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively | At weeks 24 and 48 |
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Inclusion Criteria:
NOTE: Data are insufficient to exclude a clinically important interaction of LPV/r with drugs, such as hormonal contraceptives, that are highly metabolized by the cytochrome P450 enzyme system. As a result, hormonal contraception is not considered adequate.
Exclusion Criteria:
Patient with active AIDS-defining opportunistic infection in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
Patient has a weighted genotypic score for etravirine ≥3 . (See Appendix D)
Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V).
History of active substance abuse.
Pregnant at time of screening evaluation or breast-feeding.
Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen.
Serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient
Malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
Undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
HBV co-infection
Laboratory results within 30 days prior to the first dose of study medication:
Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.
Immunomodulating agents, such as systemic corticosteroids, interleukins, or interferon's within 4 weeks prior to study entry, or patients who have received an HIV immunotherapeutic vaccine within 3 months prior to entry. Asthmatic patients using inhaled corticosteroids are eligible for enrollment.
Methadone therapy
Foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
Taking astemizole, terfenadine, cisapride, oral midazolam, triazolam, flecainide, pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or ergot derivatives.
Allergy to any of the study drugs or any excipients therein.
Patient requires inhaled or intranasal fluticasone.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph C. Gathe, Jr., MD | Therapeutic Concepts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutic Concepts, PA | Houston | Texas | 77004 | United States |
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| 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 |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
| C451734 | etravirine |
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| 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 |