This trial is concluded. This means the trial has been completed. When the results of the trial have been made public, they will be summarised in the 'outcomes' section of this page. You cannot enrol in this trial.
About this trial
This study is looking for people who take or have taken nevirapine as part of their drug regimen. The study wants to see if there are any genetic differences which may help predict who is likely to react badly to the drug.
People who have experienced nevirapine-related toxicities will be compared with those who have taken the drug and had no adverse reactions. The study will evaluate whether there are specific human genesThe most basic unit of genetic information. that either protect someone from the side effects of severe liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood. damage or skin rash or whether there are genes that allow these side effects to occur.
There are no treatments associated with this study. It is observational only. Bloods will be taken at the first visit and then six months later.
Background information
Rash is a common side effectAn unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time. of nevirapine. About 7% of people in clinical trials developed a rash within the first 6 weeks of starting on the drug. These rashes are usually mild but can be severe and life threatening which is why it is so important to keep your doctor informed of any signs.
Symptoms of liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood. toxicity are less common but can appear up to 18 weeks after starting on nevirapine. Women who are treatment-naive and have CD4 counts above 250 and treatment-naive men with counts above 400 are more likely to develop liver toxicty.
When skin, liver or hypersensitivity reactions are severe, nevirapine must be stopped permanently.
| Official title: | A Case and Control Toxicogenomics Study to Identify Genetic Locus or Loci in Patients Who Have Experienced Symptomatic Hepatotoxicity and Severe Skin Reactions Within the First 8 Weeks of Nevirapine Therapy |
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| What is this trial studying? | Side effect management |
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| How many participants will this trial enrol? | 1052 The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic. |
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| How long is this trial planned to go for? | Participants in this trial will be asked to follow the trial protocol for 6 months. |
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| Links to further information: | |
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| Can I access this treatment other than by enrolling in this trial? | Nevirapine is a licensed s100 drug
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| Tags: | hepatotoxicity, liver disorders, treatment side effects |
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Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 18 years old
- Have taken HIV treatments in the past
- Currently taking nevirapine OR have taken nevirapine in the past
- CASE patients: have experienced one or more of the following adverse reactions within the first 8 weeks of starting therapy: (a) elevation of the liver health marker LFT more than 5 times normal, along with any symptom consistent with clinical hepatitis (b) Acute liver failure after taking nevirapine (c) Nevirapine-related skin rash reaction
- CONTROL patients: You have had nevirapine for more than 18 weeks, and never had any of the symptoms described above.
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
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