Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agent… (NCT01227590) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)
United States18 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetic drug interaction study to evaluate the effects of African potato(hypoxis obtusa) on the PK of lopinavir/ritonavir.