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Completed

NCT Number: NCT00872872

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

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.

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Key information

Conditions

NVP Plasma Level 3TC Related Mutation NVP Related Mutation

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study
  • Female and aged between 18-45 years
  • Documented HIV-1 infection
  • Pregnant for a maximum of 36 weeks at the first dose of study medication
  • Baseline CD4 cell count >250 cells/mm3
  • Intend to discontinue ART after delivery

Exclusion criteria

  • History of significant reaction or allergy to the drugs that may be used in the study
  • Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV
  • Documented NVP- or 3TC-resistant HIV-1 strains
  • Concomitant use of medications that interfere with NVP plasma level
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) >1.25 times the upper limit of normal
  • Inability to understand the nature and extent of the trial procedures required
  • Pregnant woman, in the opinion of the investigator, should not participate in the study

Treatment and study plan

AZT/3TC 2 weeks after delivery

Drug

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.

Primary outcomes

  1. Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation

    Time frame: Week 1, 2, 3 and 4 after NVP discontinuation

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

  • Chulalongkorn University
  • Queen Savang Vadhana Memorial Hospital, Thailand

Registry information

Official study title

Nevirapine Plasma Level After Discontinuation of Short-term Antiretroviral Treatment for the Prevention of Mother-to-child Transmission of HIV and Development of Drug Resistant HIV-1 Variants With 1 or 2 Weeks Continuation of Zidovudine/Lamivudine in Women After Delivery

Important dates

Study start
2008
Primary completion
2019
Study completion
2021
First posted
Mar 31, 2009
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.