CompletedPhase 2

Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth

Thailand175 participantsStarted 2006-06

Plain-language summary

The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir/ritonavir (LPV/r) will also be studied. Study hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).

Who can participate

Age range

18 Years

Sex

FEMALE

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 for Mothers: * HIV infected * Pregnant with a viable fetus * Between 28 and 38 weeks of pregnancy * CD4 count greater than 250 cells/mm3 within 30 days prior to study entry * Able to receive oral ART during labor * Willing to use acceptable forms of contraception while on study treatment * Able to provide written informed consent Exclusion Criteria for Mothers: * Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV * Any ART other than ZDV during a previous pregnancy or the current pregnancy * Certain medications * Planning to receive additional ART during the first 8 weeks postpartum * Planning to breastfeed * Unlikely to comply with postpartum study requirements, in the opinion of the investigator * Certain abnormal laboratory values within 30 days prior to study entry

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

The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).

Timeframe: within 8 weeks postpartum.

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma

Timeframe: at Day 10 or Week 6 postpartum.

Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Trial details

NCT IDNCT00109590

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2012-06-26

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