Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir) (AP6142)
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ClinicalTrials.gov Identifier: NCT01227590 |
Recruitment Status
:
Completed
First Posted
: October 25, 2010
Last Update Posted
: May 7, 2015
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Condition or disease | Intervention/treatment | Phase |
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Drug Interactions Human Immunodeficiency Virus | Drug: Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir) |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | September 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Pharmacokinetics single-arm
The baseline PK of LPV/r will be established after 14 days of taking LPV/r at a dose of 400/100 mg twice daily. This will be followed by a 7 day course of LPV/r and AP together. The AP dose to be administered will be 15 mg/kg/day of hypoxoside.
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Drug: Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa)
The baseline PK of LPV/r will be established after 14 days of taking LPV/r at a dose of 400/100 mg twice daily. This will be followed by a 7 day course of LPV/r and AP together. The AP dose to be administered will be 15 mg/kg/day of hypoxoside.
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- Pharmacokinetic drug interaction study to evaluate the effects of African potato(hypoxis obtusa) on the PK of lopinavir/ritonavir. [ Time Frame: 35 days ]The study is to evaluate the effects of African Potato (hypoxis obtusa) on the steady state PK of lopinavir/ritonavir by measurement of the PK parameters of LPV/r in presence and absence of AP in healthy volunteers. The baseline PK of LPV/r will be established after 14 days of taking LPV/r at a dose of 400/100 mg twice daily. This will be followed by a 7 day course of LPV/r and hypoxoside (15 mg/kg/day) together. PK analysis of LPV/r will be repeated following the 7 days of co-administration. Each subject will act as their own control.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Absence of HIV infection prior to study entry.
- Male or female aged 18-60 who are able to provide informed consent.
- Subject is within 20%(+/-) of ideal body weight and must weigh at least 550kg
- Healthy subjects without evidence of acute or chronic illness including diabetes, hypertension, CAD, psychiatric illnesses, renal or hepatic impairment.
- Screening laboratory tests that are normal or deemed not clinically significant by the study physician
- Female subjects of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include use of an intrauterine device (IUD), oral, implanted or injected contraceptives, and barrier methods with spermicide.
- Subjects must sign an informed consent that complies with US Regulations (US 21 CFR 50) and the International Conference on Harmonization (ICH) guidelines prior to undergoing any study-related procedures.
- Subjects agreed to abstain from consuming grapefruit or its juice for at least 48 hours prior to dosing and throughout the study period until the last blood samples were being obtained.
- Subjects agreed to abstain from consuming alcohol /alcoholic beverages for at least 24 hours prior to dosing and throughout the study period until the last blood sample were being obtained.
- Subjects agreed to abstain from use of cigarettes and tobacco products for at least 24 hours prior to dosing and throughout the study period until the last blood samples were being obtained.
- Subjects who agreed to be available for the entire study period and had the ability to understand and communicate with the investigators and staff.
Exclusion Criteria:
- Use of illicit drugs or alcohol that could interfere with the completion of the study.
- Use of any over- the- counter or prescribed drugs unless approved by the principal investigator or study physician.
- Use of drugs that are known to inhibit/ induce CYP450 isozymes or are substrates of CYP3A4, CYP2D6, CYP2C8 enzymes. (use of hormonal contraceptives is permitted except for oral contraceptives)
- Pregnant or breast- feeding.
- History of acute or chronic illnesses, such as diabetes, hypertension, CAD, psychiatric illnesses, renal or hepatic impairment.
- Evidence of acute illness.
- Family history of congenital prolongation of QTc interval or with any conditions known to prolong QTc interval, such as cardiac arrhythmias, bradycardia or severe heart disease
- History of hypokalemia, hypomagnesemia or hypercholesteremia

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): NCT01227590
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94110 |
Principal Investigator: | Francesca T Aweeka, Pharm.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01227590 History of Changes |
Other Study ID Numbers: |
H2629-34853 |
First Posted: | October 25, 2010 Key Record Dates |
Last Update Posted: | May 7, 2015 |
Last Verified: | May 2015 |
Keywords provided by University of California, San Francisco:
Herbal medicine African Potato Hypoxis obtusa Drug interaction HIV Infections |
Acquired Immunodeficiency Syndrome Healthy Subjects Anti-retroviral Agents Lopinavir Ritonavir |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir |
Lopinavir Anti-Retroviral Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |