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

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ClinicalTrials.gov Identifier: NCT00872872
Recruitment Status : Active, not recruiting
First Posted : March 31, 2009
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
NVP Plasma Level NVP Related Mutation 3TC Related Mutation Drug: AZT/3TC 2 weeks after delivery

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : May 2008
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: AZT/3TC 1 week after delivery
AZT/3TC 1week after delivery
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.
Experimental: AZT/3TC 2 weeks after delivery
AZT/3TC 2 weeks after delivery
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.


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872872


Locations
Thailand
Thai Red Cross AIDS Research Centre
Patumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Chulalongkorn University
Queen Savang Vadhana Memorial Hospital, Thailand
More Information

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT00872872     History of Changes
Other Study ID Numbers: HIV-NAT 094
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Thai Red Cross AIDS Research Centre:
NVP
PMTCT
pregnancy
resistance

Additional relevant MeSH terms:
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers