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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The study is being conducted to evaluate whether African potato, an herbal medicine, can be used together with anti-HIV medicines without affecting the amounts of the anti-HIV medicines in the blood. African potato is an African herbal medicine widely used in Africa, particularly sub-Saharan Africa. Although it has not been proven, it is believed to help boost the immune system. Similar studies have been done on herbal medicines especially those that are used in developing countries. In some cases, the herbal treatments can affect the blood levels of other medicines when the medicines are used together. This study will measure the effect of African potato on lopinavir/ritonavir (Kaletra®), a common anti-HIV medicine. Lopinavir/ritonavir is approved by the United States Food and Drug Administration (FDA). The information obtained from this study will tell us if African potato and anti-HIV treatments can be used together to treat HIV infected patients in Africa and other resource poor regions.

Condition or disease Intervention/treatment Phase
Drug Interactions Human Immunodeficiency Virus Drug: Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa) Phase 1

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Francesca T Aweeka, Pharm.D. University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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