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NCT01227590 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)
A Phase 1 study of Human Immunodeficiency Virus and Drug Interactions, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01227590: Completed Phase 1 study of Human Immunodeficiency Virus and Drug Interactions, sponsored by University of California, San Francisco.
NCT01227590 is a Phase 1 study of Human Immunodeficiency Virus and Drug Interactions that has completed, run by University of California, San Francisco. The registered enrollment target is 18 participants, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227590, a Phase 1 study of Human Immunodeficiency Virus and Drug Interactions, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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. Ea
Conditions Studied
Interventions
- DRUG Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa)
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01227590 record still lists
NCT01227590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa) is the first listed.
NCT01227590 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01227590 about?
NCT01227590 is a clinical study titled "Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)". 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....
What is the current status of trial NCT01227590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-02. Estimated completion is 2011-09.
What conditions does trial NCT01227590 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus, Drug Interactions.
What interventions are being tested in trial NCT01227590?
The interventions under investigation include: Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa) (DRUG).
Who is sponsoring clinical trial NCT01227590?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01227590 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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