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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Thai Red Cross AIDS Research Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chulalongkorn University
Queen Savang Vadhana Memorial Hospital
Information provided by:
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT00872872
First received: March 30, 2009
Last updated: September 20, 2009
Last verified: September 2009
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872872

Contacts
Contact: Nittaya Phanuphak, MD 662 253 0996 nittaya.p@chula.ac.th

Locations
Thailand
Thai Red Cross AIDS Research Centre Recruiting
Patumwan, Bangkok, Thailand, 10330
Contact: Nittaya Phanuphak, MD     662 253 0996     nittaya.p@chula.ac.th    
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Chulalongkorn University
Queen Savang Vadhana Memorial Hospital
  More Information

No publications provided

Responsible Party: Nittaya Phanuphak, Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT00872872     History of Changes
Other Study ID Numbers: HIV-NAT 094
Study First Received: March 30, 2009
Last Updated: September 20, 2009
Health Authority: Thailand: Institutional Review Board

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

Additional relevant MeSH terms:
Zidovudine
Nevirapine
Lamivudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013