NVP Plasma LevelNCT00872872
Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)
A study testing AZT/3TC 2 weeks after delivery in people with NVP Plasma Level and NVP Related Mutation, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- NVP Plasma Level, NVP Related Mutation, 3TC Related Mutation
- What is being tested?
- AZT/3TC 2 weeks after delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- May 2008to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study
- Female and aged between 18-45 years
- Documented HIV-1 infection
- Pregnant for a maximum of 36 weeks at the first dose of study medication
- Baseline CD4 cell count >250 cells/mm3
- Intend to discontinue ART after delivery
Who cannot join
- History of significant reaction or allergy to the drugs that may be used in the study
- Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV
- Documented NVP- or 3TC-resistant HIV-1 strains
- Concomitant use of medications that interfere with NVP plasma level
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >1.25 times the upper limit of normal
- Inability to understand the nature and extent of the trial procedures required
- Pregnant woman, in the opinion of the investigator, should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- NVP Plasma Level, NVP Related Mutation, 3TC Related Mutation
- Being tested
- AZT/3TC 2 weeks after delivery
- Keywords
- NVP, PMTCT, pregnancy, resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZT/3TC 2 weeks after deliveryDrug
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 group | Role | What they receive |
|---|---|---|
| AZT/3TC 1 week after delivery | Active comparator | AZT/3TC 1week after delivery Receives: Drug: AZT/3TC 2 weeks after delivery |
| AZT/3TC 2 weeks after delivery | Experimental | AZT/3TC 2 weeks after delivery Receives: Drug: AZT/3TC 2 weeks after delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation
Measured: Week 1, 2, 3 and 4 after NVP discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionApr 2019
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NVP Plasma LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Queen Savang Vadhana Memorial Hospital, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872872
- Sponsor's protocol ID
- HIV-NAT 094
- Status last verified
- Jul 2021
- First submitted
- 30 Mar 2009
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00872872
- Acronym / sponsor ID
- HIV-NAT 094
- Conditions
- NVP Plasma Level, NVP Related Mutation, 3TC Related Mutation
- Keywords
- NVP, PMTCT, pregnancy, resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Queen Savang Vadhana Memorial Hospital, Thailand
- Study start
- May 2008
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZT/3TC 1 week after delivery | Active comparator | Drug: AZT/3TC 2 weeks after deliveryAZT/3TC 1week after delivery |
| AZT/3TC 2 weeks after delivery | Experimental | Drug: AZT/3TC 2 weeks after deliveryAZT/3TC 2 weeks after delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study
- Female and aged between 18-45 years
- Documented HIV-1 infection
- Pregnant for a maximum of 36 weeks at the first dose of study medication
- Baseline CD4 cell count >250 cells/mm3
Key exclusion criteria (7 listed)
- History of significant reaction or allergy to the drugs that may be used in the study
- Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV
- Documented NVP- or 3TC-resistant HIV-1 strains
- Concomitant use of medications that interfere with NVP plasma level
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >1.25 times the upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZT/3TC 2 weeks after deliveryAZT/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. | Drug | AZT/3TC 1 week after delivery, AZT/3TC 2 weeks after delivery |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AZT/3TC 2 weeks after delivery in people with NVP Plasma Level and NVP Related Mutation, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.