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Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)

NCT01227590 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-05-07

No results posted yet for this 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.

Conditions

  • Drug Interactions
  • Human Immunodeficiency Virus

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Francesca T Aweeka, Pharm.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-02-28
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227590 on ClinicalTrials.gov