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Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)

NCT00872872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-07-12

No results posted yet for this study

Summary

Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected pregnant women worldwide, both for the prevention of mother to child transmission of HIV (PMTCT) and for women's own health. Use of these drugs in pregnant women solely for PMTCT means that these drugs will need to be discontinued in the majority of women after delivery.

Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the body for a longer period of time after discontinuation than other drugs in the same regimen), such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the only drug left in the body (similar to monotherapy). Given two other drugs for up to 1 week after discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can help reduce, but not eliminate, the development of resistant virus.

Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women in developing countries due to its low cost and its availability in fixed-dose combinations. These study will explore how fast NVP is eliminated from women after delivery and to see if given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help reduce the development of NVP resistant virus.

Conditions

  • NVP Plasma Level
  • NVP Related Mutation
  • 3TC Related Mutation

Interventions

DRUG

AZT/3TC 2 weeks after delivery

AZT/3TC 300/150mg will be given every 12 hours for 1 week after NVP discontinuation in arm 1 and for 2 weeks after NVP discontinuation in arm 2.

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • Queen Savang Vadhana Memorial Hospital, Thailand

    collaborator OTHER

  • Thai Red Cross AIDS Research Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2019-04-30
Completion
2021-04-30

Countries

  • Thailand

Study Locations

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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 NCT00872872 on ClinicalTrials.gov