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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00872872

Enrollment

Registered

2009-03-31

Start date

2008-05-31

Completion date

2021-04-30

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3TC Related Mutation, NVP Plasma Level, NVP Related Mutation

Keywords

NVP, PMTCT, pregnancy, resistance

Brief 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.

Interventions

DRUGAZT/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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study 2. Female and aged between 18-45 years 3. Documented HIV-1 infection 4. Pregnant for a maximum of 36 weeks at the first dose of study medication 5. Baseline CD4 cell count \>250 cells/mm3 6. Intend to discontinue ART after delivery

Exclusion criteria

1. History of significant reaction or allergy to the drugs that may be used in the study 2. Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV 3. Documented NVP- or 3TC-resistant HIV-1 strains 4. Concomitant use of medications that interfere with NVP plasma level 5. Serum aspartate transaminase (AST) or alanine transaminase (ALT) \>1.25 times the upper limit of normal 6. Inability to understand the nature and extent of the trial procedures required 7. Pregnant woman, in the opinion of the investigator, should not participate in the study

Design outcomes

Primary

Measure	Time frame
Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation	Week 1, 2, 3 and 4 after NVP discontinuation

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026