SSAT063- Pharmacokinetics of Efavirenz 400 mg Once Daily During Pregnancy in HIV-1 Infected Women

• Status: Completed
• Trial end date: 2017-10-05
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to measure the drug levels in your blood and to find out whether a reduced dose (400mg) of the anti-HIV medication Efavirenz is safe when taken during pregnancy.

The study will recruit HIV infected women who take Efavirenz as part of their anti-hiv treatment and who are pregnant.

Efavirenz has been shown to be safe in pregnancy and at the standard dose that everybody takes of 600mg once a day, it shows levels that are enough to treat HIV and give birth to a HIV negative baby.

Efavirenz at a dose of 400mg once daily works against HIV too but this dose has not been given to HIV positive pregnant women.

People with HIV may benefit from using a dose of efavirenz of 400mg instead of 600mg, as lower drug doses could have fewer side effects and be tolerated better.

Dose reduction would also make the drug cheaper. This would allow more people to be treated and free up money for other important work in the fight against HIV such as education and prevention programs.

However, it is not known whether 400mg of Efavirenz works as well as 600mg of Efavirenz during pregnancy and this is why the investigators are conducting this study, which aims to measure the amount of Efavirenz 400mg in HIV pregnant women's bodies when they are taking 400mg of Efavirenz once a day.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Stephens Aids Trust
• Collaborator: Mylan Inc.
• Treatments: Efavirenz; Emtricitabine; Lamivudine; Lamivudine, zidovudine drug combination; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.

2. HIV-1-infected pregnant female, stable on two nucleos/tide analogues (tenofovir/emtricitabine or tenofovir/lamivudine or zidovudine/lamivudine) and efavirenz 600mg once daily for more than 12 weeks and willing to take efavirenz 400 mg once daily at gestational age of 28 weeks +/- 3 weeks.

3. Undetectable viral load (by local assay).

4. CD4 count > 100 cells/mm3.

5. Aged between 18 to 45 years, inclusive.

Exclusion Criteria:

1. Viral load ≥ 50 copies/mL (or detectable by local assay).

2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.

3. Positive blood screen for chronic hepatitis C (if available locally) or hepatitis B.

4. Current or recent (within 3 months) gastrointestinal disease.

5. Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events.

6. Exposure to any investigational drug or placebo within 3 months prior to first dose of study drug.

7. Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.