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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2021-04-30

Brief Summary

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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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Detailed Description

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Conditions

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NVP Plasma Level NVP Related Mutation 3TC Related Mutation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AZT/3TC 1 week after delivery

AZT/3TC 1week after delivery

Group Type ACTIVE_COMPARATOR

AZT/3TC 2 weeks after delivery

Intervention Type 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.

AZT/3TC 2 weeks after delivery

Group Type EXPERIMENTAL

AZT/3TC 2 weeks after delivery

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No