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AzTrials

HIV InfectionsPhase 2NCT00142337

One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

A Phase 2 study testing Zidovudine (ZDV) and Didanosine (ddI) in people with HIV Infections, run by Institut de Recherche pour le Developpement at 32 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP) resistance mutations postpartum in women who received a single dose of nevirapine during labor and standard ZDV prophylaxis for the… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine (ZDV) and Didanosine (ddI)
How many people
244 participants
Where
32 sitesThailand
Study dates
Dec 2004to Feb 2009
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet all pre-entry criteria;
  • Consent to participate and to be followed for the duration of the study;
  • Present the following laboratory values within 14 days prior to inclusion:
  • Hemoglobin > 8.0 mg/dl
  • Absolute neutrophil count > 1000 cells/mm3
  • Platelets > 100,000 cells/mm3
Show all 9Show fewer
  • Serum creatinine < 1.5 mg/dl (women with a serum creatinine > 1.5 mg/dl must have a measured eight-hour urine creatinine clearance > 70 ml/min)
  • SGPT less than 10 times the upper limit of normal
  • Amylase less than 150/L IU (this upper limit may change slightly depending on the normal range at the hospital laboratory).

Who cannot join

  • Evidence of pre-existing fetal anomalies incompatible with life;
  • Known hypersensitivity to any benzodiazepine or to NVP;
  • Receipt of antiretroviral agent other than ZDV;
  • Receipt of non-allowed concomitant treatment or contraindication to ddI
  • Concurrent participation in another clinical trial;
  • Women with a CD4 count <200/µL or history of oral candidiasis if they are not receiving pneumocystis carinii pneumonia (PCP) prophylaxis
  • Any other contra-indicated drugs during ZDV+ddI treatment for the mother as well as the child (Contra-indicated drugs such as gancyclovir, isoniazid, linezolid, ethambutol, rifabutin, cidofovir are not allowed during the ZDV ddI treatment after delivery in order to prevent pharmacological interactions or overlapping toxicities.)

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Thailand32 sites

  • Bhumibol Adulyadej Hospital

    Bangkok, Bangkok, 10220

  • Health Promotion Hospital Regional Center I

    Bangkok, Bangkok, 10220

  • Chiang Kham Hospital

    Chiang Kham, Changwat Phayao, 56110

  • Somdej Pranangchao Sirikit Hospital

    Chon Buri, Changwat Chon Buri, 20180

  • Hat Yai Hospital

    Hat Yai, Changwat Songkhla, 90110

  • Kranuan Crown Prince Hospital

    Kranuan, Changwat Khon Kaen, 40170

  • Mae Chan Hospital

    Mae Chan, Changwat Chiang Rai, 57110

  • Nakornping Hospital

    Mae Rim, Chiang Mai, 50180

  • Mae Sai Hospital

    Mae Sai, Changwat Chiang Rai, 57130

  • Chacheongsao Hospital

    Muang, Chacheongsao, 24000

  • Prapokklao Hospital

    Muang, Changwat Chanthaburi, 22000

  • Chonburi Hospital

    Muang, Changwat Chon Buri, 20000

  • Kalasin Hospital

    Muang, Changwat Kalasin, 46000

  • Khon Kaen Hospital

    Muang, Changwat Khon Kaen, 40000

  • Regional Health Promotion Centre 6, Khon Kaen

    Muang, Changwat Khon Kaen, 40000

  • Srinagarind Hospital

    Muang, Changwat Khon Kaen, 40002

  • Lampang Hospital

    Muang, Changwat Lampang, 52000

  • Nong Khai Hospital

    Muang, Changwat Nong Khai, 43000

  • Pranangklao Hospital

    Muang, Changwat Nonthaburi, 11000

  • Buddhachinaraj Hospital

    Muang, Changwat Phitsanulok, 65000

  • Ratchaburi Hospital

    Muang, Changwat Ratchaburi, 70000

  • Rayong Hospital

    Muang, Changwat Rayong, 21000

  • Roi-et Hospital

    Muang, Changwat Roi Et, 45000

  • Health Promotion Center Region 10

    Muang, Chiang Mai, 50100

  • Chiangrai Prachanukroh Hospital

    Muang, Chiangrai, 57000

  • Nakhonpathom Hospital

    Muang, Nakhonpathom, 73000

  • Maharaj Nakornratchasrima Hospital

    Muang, Nakornratchasrima, 30000

  • Samutsakorn Hospital

    Muang, Samutsakorn, 74000

  • Lamphun Hospital

    Munag, Chiang Mai, 51000

  • Phaholpolphayuhasena Hospital

    Munag, Kanchanaburi, 71000

  • Phan Hospital

    Phan, Changwat Chiang Rai, 57120

  • Samutprakarn Hospital

    Samutprakarn, Samutprakarn, 10280

Other trials in Thailand

About this study

Official title: A Phase 2, One Arm, Open Label, Feasibility Study Assessing One Month Zidovudine/Didanosine Postpartum Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine to Prevent Mother to Child Transmission of HIV

The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP) resistance mutations postpartum in women who received a single dose of nevirapine during labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV.

Read the detailed description

A single nevirapine dose to the mother, with or without a dose to the child, in addition to oral ZDV prophylaxis starting from 28 weeks gestation has been proven to be highly effective in reducing further mother-to-child HIV transmission (PMTCT).

However, post exposure nevirapine resistance mutations are observed in the mother's viral population. These mutations detectable very early after exposure tend to disappear over time.

Nevertheless, they may be associated with decrease in efficacy of non-nucleoside reverse transcriptase inhibitor (NNRTI) containing regimens subsequently given to the women for their own health.

Therefore, there is a need for research to prevent selection of resistance in the first place or to overcome the resistance in subsequent treatment of the infected mother or infant.

Nevirapine plasma levels above IC50 have been detected in women exposed to a single 200 mg dose of nevirapine in a significant number of women during the third week postpartum.

We hypothesize that giving ZDV+ddI to women exposed to nevirapine for one month as soon as possible after exposure may prevent the selection of nevirapine resistance mutations.

Conditions
HIV Infections
Being tested
Zidovudine (ZDV), Didanosine (ddI)
Keywords
zidovudine, didanosine, Prevention of mother to child transmission of HIV, nevirapine, Thailand, Resistance, HIV, Postpartum period
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zidovudine (ZDV)Drug

    Zidovudine 300 mg, twice daily, for one month postpartum. Note: after July 03, 2005, all women received 200 mg, twice daily, for the same duration.

  • Didanosine (ddI)Drug

    250 mg ddI-EC (400 mg if body weight >60 kg) once daily, starting at the onset of labor and for one month postpartum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with viral NNRTI mutations detectable during the 4 month follow-up compared with the incidence observed in the PHPT-2 clinical trial, who received the same antiretroviral prophylaxis but no post-partum regimen

    Measured: Within 4 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionMay 2006
  4. Study completionFeb 2009

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00142337
Sponsor's protocol ID
IRD-UMI 174 PHPT-4
Status last verified
Jan 2012
First submitted
1 Sep 2005
Last updated
6 Jan 2012
Results posted
No

Publications

  • Lallemant M, Jourdain G, Le Coeur S, Mary JY, Ngo-Giang-Huong N, Koetsawang S, Kanshana S, McIntosh K, Thaineua V; Perinatal HIV Prevention Trial (Thailand) Investigators. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004 Jul 15;351(3):217-28. doi: 10.1056/NEJMoa033500. Epub 2004 Jul 9.

    PubMed 15247338

  • Jourdain G, Ngo-Giang-Huong N, Le Coeur S, Bowonwatanuwong C, Kantipong P, Leechanachai P, Ariyadej S, Leenasirimakul P, Hammer S, Lallemant M; Perinatal HIV Prevention Trial Group. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N Engl J Med. 2004 Jul 15;351(3):229-40. doi: 10.1056/NEJMoa041305. Epub 2004 Jul 9.

    PubMed 15247339

  • Cressey TR, Jourdain G, Lallemant MJ, Kunkeaw S, Jackson JB, Musoke P, Capparelli E, Mirochnick M. Persistence of nevirapine exposure during the postpartum period after intrapartum single-dose nevirapine in addition to zidovudine prophylaxis for the prevention of mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr. 2005 Mar 1;38(3):283-8.

    PubMed 15735445

  • Lallemant M, Ngo-Giang-Huong N, Jourdain G, Traisaithit P, Cressey TR, Collins IJ, Jarupanich T, Sukhumanant T, Achalapong J, Sabsanong P, Chotivanich N, Winiyakul N, Ariyadej S, Kanjanasing A, Ratanakosol J, Hemvuttiphan J, Kengsakul K, Wannapira W, Sittipiyasakul V, Pornkitprasarn W, Liampongsabuddhi P, McIntosh K, Van Dyke RB, Frenkel LM, Koetsawang S, Le Coeur S, Kanchana S; PHPT-4 Study Team. Efficacy and safety of 1-month postpartum zidovudine-didanosine to prevent HIV-resistance mutations after intrapartum single-dose nevirapine. Clin Infect Dis. 2010 Mar 15;50(6):898-908. doi: 10.1086/650745.

    PubMed 20158398

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zidovudine (ZDV) and Didanosine (ddI) in people with HIV Infections, run by Institut de Recherche pour le Developpement at 32 sites 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 9 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 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 viral NNRTI mutations detectable during the 4 month follow-up compared with the incidence observed in the PHPT-2 clinical trial, who received the same antiretroviral prophylaxis but no post-partum regimen (time frame: Within 4 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00142337, which also lists 4 linked publications.

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 6 Jan 2012.

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