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

• Sponsor: Thai Red Cross AIDS Research Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00872872
• Collaborator: Chulalongkorn University (Other), Queen Savang Vadhana Memorial Hospital, Thailand (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 155
• Patients Per Site Per Month: 0.2

Study Details

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	Phase
NVP Plasma Level; NVP Related Mutation; 3TC Related Mutation	Drug: AZT/3TC 2 weeks after delivery	N/A

Study Design

• Study Type: Interventional
• 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 1, 2008
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2021

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 [Week 1, 2, 3 and 4 after NVP discontinuation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Thai Red Cross AIDS Research Centre	Bangkok		Thailand	10330

Sponsors and Collaborators

• Thai Red Cross AIDS Research Centre
• Chulalongkorn University
• Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thai Red Cross AIDS Research Centre
• ClinicalTrials.gov Identifier: NCT00872872
• Other Study ID Numbers: HIV-NAT 094
• First Posted: Mar 31, 2009
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

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

Study Results

No Results Posted as of Jul 12, 2021