HIV InfectionsPhase 3NCT00086359
Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV
A Phase 3 study testing Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine and Lopinavir/ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
Trial summary
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from… Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine and Lopinavir/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2004to Sep 2007
- Phase
- Phase 3
- 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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV infected
- Between the 12th and 30th week of pregnancy
- Intend to continue pregnancy
- Viral load less than 55,000 copies/ml within 30 days of study entry
- CD4 count greater than 350 cells/ml within 30 days of study entry
- Have not previously taken anti-HIV medications (women who have taken 8 weeks or fewer of zidovudine are still eligible) OR have taken anti-HIV medication but have been off treatment for more than 180 days
Show all 10Show fewer
- Intend to stop taking anti-HIV medications after pregnancy
- Willing to have her infant tested for HIV
- Parent or guardian willing to provide informed consent, if applicable
- Have access to a participating site and are willing to be followed for the duration of the study
Who cannot join
- Chemotherapy for active cancer
- Active opportunistic infection or severe medical condition within 14 days of study entry
- Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry
- Certain abnormal laboratory values
- Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded.
- Current alcohol or other substance abuse that, in the opinion of the investigator, may interfere with the study
Show all 12Show fewer
- Acute hepatitis within 90 days of study entry
- Major birth defects in infant
- Severe skin disorder (e.g., eczema or psoriasis) requiring systemic treatment
- Require certain medications
- Medical condition that may, in the opinion of the investigator, interfere with the study
- Intend to breastfeed
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, 60608
Texas Children's Hosp. CRS
Houston, Texas, 77030
Usc La Nichd Crs
Los Angeles, California, 90033
Regional Med. Ctr. at Memphis
Memphis, Tennessee, 38105-2794
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33136
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103
Bronx-Lebanon CRS
The Bronx, New York, 10457
About this study
Official title: A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).
Read the detailed description
Antiretroviral therapy (ART) in pregnancy has dramatically reduced the rates of perinatal HIV transmission. Many pregnant women infected with HIV may not meet the criteria for treatment as set forth by the Department of Health and Human Services' guidelines and would not be started on therapy if they were not pregnant. Pregnant women are prescribed a variety of treatment regimens; the optimum regimen for pregnant women who plan to discontinue therapy after delivery is unknown. An optimum regimen would account for the need for maximum viral suppression, minimal fetal toxicity, and preservation of future therapeutic options for the mother. This study will compare an all nucleoside reverse transcriptase inhibitor (NRTI) regimen of ABC/3TC/ZDV with a standard protease inhibitor (PI) regimen of LPV/RTV and 3TC/ZDV. This study was initially designed for women who plan to take antiretrovirals only while pregnant and do not meet the criteria for treatment initiation if not pregnant. However, pregnant women who have taken ART for 180 days or less or have taken ZDV monotherapy for a total of 8 weeks or less prior to entering this study are eligible for Version 2.0 of this study.
Women in this study will be randomly assigned to one of two groups. Women in Group A will receive one pill ABC/3TC/ZDV twice a day. Women in Group B will receive one pill 3TC/ZDV and 4 pills LPV/RTV twice a day. Women will take their assigned medications until they go into labor. Once in labor, women will be given zidovudine through intravenous (IV) infusion; they will stop taking oral zidovudine but will continue with their other medications. After delivery, all infants will be given zidovudine for six weeks.
Women will have study visits every 2 weeks for the first 8 weeks of treatment, and then every 4 weeks until Week 28. Depending on where a woman is in her pregnancy when she enrolls in the study, she will also have study visits at Weeks 20, 28, and 34 of her pregnancy. At each visit, women will have a medical interview, a physical exam, and an obstetrical exam; blood and urine collection will occur at these visits. Mothers will undergo a fetal ultrasound at Week 20. Adherence, health status, and behavior assessments will occur at selected visits prior to delivery.
After delivery, women will stop taking the study medications but will continue to have study visits at approximately 6, 12, 24, 36, 48, and 52 weeks after delivery. Medical history and a physical exam will occur at all visits for mothers postpartum. Blood collection will occur at every postpartum visit; urine collection will occur 12, 24, and 48 weeks postpartum; health status and behavior assessments will occur at most visits postpartum. Infants will have study visits at 2, 16, and 24 weeks after birth. A medical history, physical exam, and laboratory tests will be conducted at the infant study visits. Women will also be asked to enroll their infants in PACTG 219C, a long-term study that follows infants who are born to HIV infected mothers.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine, Lopinavir/ritonavir
- Keywords
- Treatment Naive, Perinatal Transmission, Mother-to-Child Transmission, MTCT, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfate, lamivudine, and zidovudineDrug
one pill twice daily
Lamivudine/zidovudineDrug
one pill twice daily
Lopinavir/ritonavirDrug
four pills twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | One pill of abacavir/lamivudine/zidovudine twice daily Receives: Drug: Abacavir sulfate, lamivudine, and zidovudine |
| B | Experimental | One pill of zidovudine/lamivudine and four pills of lopinavir/ritonavir twice daily. Receives: Drug: Lamivudine/zidovudine; Drug: Lopinavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women in each treatment group with virologic suppression to less than 400 copies/ml at 34th week of pregnancy (or last viral load prior to delivery, if delivery occurs before 34th week of pregnancy) while continuing on assigned therapy
Measured: at Week 34 of pregnancy
Secondary outcomes (9)
Primary outcome, evaluating ART naive and ART experienced women
Measured: throughout study
HIV-related health status of women at delivery, determined by CD4 counts and plasma HIV-1 viral load in the two treatment groups and in ART naive and ART experienced women
Measured: throughout study
study treatment adherence and health status by self report
Measured: throughout study
HIV-related health status of women postpartum, determined by CD4 counts and plasma HIV-1 viral load
Measured: at Months 3, 6 and 12 postpartum and prior to ART treatment
development of HIV-1 genotypic resistance among women in each treatment group
Measured: at delivery, Months 3, 6, and 12 postpartum, and in all cases of treatment failure
incidence of abnormal glucose tolerance, gestational diabetes, and abnormal lactate levels during pregnancy in each treatment group
Measured: throughout study
incidence of anemia, hypoglycemia, abnormal liver function studies, prematurity, low birth weight, or perinatal HIV transmission among infants born to women in each treatment group
Measured: throughout study
predictive value, sensitivity, and specificity of polymorphisms in HLA-B57, HLA-DR7, and HLA-DQ3 in identifying pregnant women at risk for development of ABC hypersensitivity
Measured: throughout study
concentration of T cell receptor rearrangement excision DNA circles
Measured: at study entry, delivery and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2004 (estimated)
- Study startJul 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Andrew D. Hull, MD, Study chair, Department of Reproductive Medicine, Division of Perinatal Medicine, University of California, San Diego School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086359
- Sponsor's protocol ID
- P1039
- Other IDs
- 10046, PACTG P1039
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Cooper ER, Charurat M, Mofenson L, Hanson IC, Pitt J, Diaz C, Hayani K, Handelsman E, Smeriglio V, Hoff R, Blattner W; Women and Infants' Transmission Study Group. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):484-94. doi: 10.1097/00126334-200204150-00009.
PubMed 11981365Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
PubMed 15332429Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
PubMed 14562860Thorne C, Newell ML. Mother-to-child transmission of HIV infection and its prevention. Curr HIV Res. 2003 Oct;1(4):447-62. doi: 10.2174/1570162033485140.
PubMed 15049430Tuomala RE, Shapiro DE, Mofenson LM, Bryson Y, Culnane M, Hughes MD, O'Sullivan MJ, Scott G, Stek AM, Wara D, Bulterys M. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med. 2002 Jun 13;346(24):1863-70. doi: 10.1056/NEJMoa991159.
PubMed 12063370
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV
- ClinicalTrials.gov ID
- NCT00086359
- Acronym / sponsor ID
- P1039
- Conditions
- HIV Infections
- Keywords
- Treatment Naive, Perinatal Transmission, Mother-to-Child Transmission, MTCT, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 1 Jul 2004 (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.
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).
Detailed description
Antiretroviral therapy (ART) in pregnancy has dramatically reduced the rates of perinatal HIV transmission. Many pregnant women infected with HIV may not meet the criteria for treatment as set forth by the Department of Health and Human Services' guidelines and would not be started on therapy if they were not pregnant. Pregnant women are prescribed a variety of treatment regimens; the optimum regimen for pregnant women who plan to discontinue therapy after delivery is unknown. An optimum regimen would account for the need for maximum viral suppression, minimal fetal toxicity, and preservation of future therapeutic options for the mother. This study will compare an all nucleoside reverse transcriptase inhibitor (NRTI) regimen of ABC/3TC/ZDV with a standard protease inhibitor (PI) regimen of LPV/RTV and 3TC/ZDV. This study was initially designed for women who plan to take antiretrovirals only while pregnant and do not meet the criteria for treatment initiation if not pregnant. However, pregnant women who have taken ART for 180 days or less or have taken ZDV monotherapy for a total of 8 weeks or less prior to entering this study are eligible for Version 2.0 of this study.
Women in this study will be randomly assigned to one of two groups. Women in Group A will receive one pill ABC/3TC/ZDV twice a day. Women in Group B will receive one pill 3TC/ZDV and 4 pills LPV/RTV twice a day. Women will take their assigned medications until they go into labor. Once in labor, women will be given zidovudine through intravenous (IV) infusion; they will stop taking oral zidovudine but will continue with their other medications. After delivery, all infants will be given zidovudine for six weeks.
Women will have study visits every 2 weeks for the first 8 weeks of treatment, and then every 4 weeks until Week 28. Depending on where a woman is in her pregnancy when she enrolls in the study, she will also have study visits at Weeks 20, 28, and 34 of her pregnancy. At each visit, women will have a medical interview, a physical exam, and an obstetrical exam; blood and urine collection will occur at these visits. Mothers will undergo a fetal ultrasound at Week 20. Adherence, health status, and behavior assessments will occur at selected visits prior to delivery.
After delivery, women will stop taking the study medications but will continue to have study visits at approximately 6, 12, 24, 36, 48, and 52 weeks after delivery. Medical history and a physical exam will occur at all visits for mothers postpartum. Blood collection will occur at every postpartum visit; urine collection will occur 12, 24, and 48 weeks postpartum; health status and behavior assessments will occur at most visits postpartum. Infants will have study visits at 2, 16, and 24 weeks after birth. A medical history, physical exam, and laboratory tests will be conducted at the infant study visits. Women will also be asked to enroll their infants in PACTG 219C, a long-term study that follows infants who are born to HIV infected mothers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Abacavir sulfate, lamivudine, and zidovudineOne pill of abacavir/lamivudine/zidovudine twice daily |
| B | Experimental | Drug: Lamivudine/zidovudine, Drug: Lopinavir/ritonavirOne pill of zidovudine/lamivudine and four pills of lopinavir/ritonavir twice daily. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- HIV infected
- Between the 12th and 30th week of pregnancy
- Intend to continue pregnancy
- Viral load less than 55,000 copies/ml within 30 days of study entry
- CD4 count greater than 350 cells/ml within 30 days of study entry
Key exclusion criteria (12 listed)
- Chemotherapy for active cancer
- Active opportunistic infection or severe medical condition within 14 days of study entry
- Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry
- Certain abnormal laboratory values
- Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded.
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 |
|---|---|---|
| Abacavir sulfate, lamivudine, and zidovudineone pill twice daily | Drug | A |
| Lamivudine/zidovudineone pill twice daily | Drug | B |
| Lopinavir/ritonavirfour pills twice daily | Drug | B |
Primary outcome
Proportion of women in each treatment group with virologic suppression to less than 400 copies/ml at 34th week of pregnancy (or last viral load prior to delivery, if delivery occurs before 34th week of pregnancy) while continuing on assigned therapy
Time frame: at Week 34 of pregnancy
9 secondary outcomes
Primary outcome, evaluating ART naive and ART experienced women
Time frame: throughout study
HIV-related health status of women at delivery, determined by CD4 counts and plasma HIV-1 viral load in the two treatment groups and in ART naive and ART experienced women
Time frame: throughout study
study treatment adherence and health status by self report
Time frame: throughout study
HIV-related health status of women postpartum, determined by CD4 counts and plasma HIV-1 viral load
Time frame: at Months 3, 6 and 12 postpartum and prior to ART treatment
development of HIV-1 genotypic resistance among women in each treatment group
Time frame: at delivery, Months 3, 6, and 12 postpartum, and in all cases of treatment failure
incidence of abnormal glucose tolerance, gestational diabetes, and abnormal lactate levels during pregnancy in each treatment group
Time frame: throughout study
incidence of anemia, hypoglycemia, abnormal liver function studies, prematurity, low birth weight, or perinatal HIV transmission among infants born to women in each treatment group
Time frame: throughout study
predictive value, sensitivity, and specificity of polymorphisms in HLA-B57, HLA-DR7, and HLA-DQ3 in identifying pregnant women at risk for development of ABC hypersensitivity
Time frame: throughout study
concentration of T cell receptor rearrangement excision DNA circles
Time frame: at study entry, delivery and 6 weeks postpartum
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 1 Nov 2021.
- Background: PubMed 11981365Cooper ER, Charurat M, Mofenson L, Hanson IC, Pitt J, Diaz C, Hayani K, Handelsman E, Smeriglio V, Hoff R, Blattner W; Women and Infants' Transmission Study Group. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):484-94. doi: 10.1097/00126334-200204150-00009.
- Background: PubMed 15332429Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
- Background: PubMed 14562860Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
- Background: PubMed 15049430Thorne C, Newell ML. Mother-to-child transmission of HIV infection and its prevention. Curr HIV Res. 2003 Oct;1(4):447-62. doi: 10.2174/1570162033485140.
- Background: PubMed 12063370Tuomala RE, Shapiro DE, Mofenson LM, Bryson Y, Culnane M, Hughes MD, O'Sullivan MJ, Scott G, Stek AM, Wara D, Bulterys M. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med. 2002 Jun 13;346(24):1863-70. doi: 10.1056/NEJMoa991159.
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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.
Andrew D. Hull, MD study chair
Department of Reproductive Medicine, Division of Perinatal Medicine, University of California, San Diego School of Medicine
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine and Lopinavir/ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
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 10 inclusion and 12 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 women in each treatment group with virologic suppression to less than 400 copies/ml at 34th week of pregnancy (or last viral load prior to delivery, if delivery occurs before 34th week of pregnancy) while continuing on assigned therapy (time frame: at Week 34 of pregnancy). 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 NCT00086359, which also lists 5 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 1 Nov 2021.