HIVPhase 2/3PregnantHIVNCT01854762
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
A Phase 2/3 study testing Raltegravir and Lopinavir/Ritonavir in people with HIV and Pregnancy, run by Fundação Bahiana de Infectologia at 1 site in Brazil.
Trial summary
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failure to ARV drugs of different classes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- What is being tested?
- Raltegravir and Lopinavir/Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2015to 2 Aug 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
- Gestational age higher than 28 weeks
- Age equal or higher than 15 years
- HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml
Who cannot join
- Age lower than 15 years
- Undetectable plasma viral load at screening
- Previous use of RAL
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fundação Bahiana de Infectologia/SEI
Salvador, Estado de Bahia, 40110-010
About this study
Official title: Evaluation of the Use of Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection in Pregnant Women Presenting With Detectable Viral Load After 32 Weeks of Gestation: a Pilot Study
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failure to ARV drugs of different classes. However, some problems are still present, especially for specific populations, like pregnant women and infants. For these groups, most of currently available drugs are not used, because the lack of information on safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child transmission (MTCT) is still a problem in certain areas of the world, especially in resource-limited settings. In some settings, women often present to their first antenatal care visit late in the pregnancy, posing an additional problem: how to effectively treat these patients to assure they will have an undetectable viral load at the moment of delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6 or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA / ml of plasma. To achieve this goal, it would be necessary the use of a potent, very efficacious ARV regimen that could provide such viral decay in a very short period. Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it has no genotoxic potential, and promotes a rapid decline in HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to be used for prevention of MTCT for women with detectable viral load, presenting late in the course of pregnancy. Another attractive point is to consider that, due to the similarity between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1); RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct, the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1 RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters pregnant women and to compare the frequency of adverse events for women using RAL-based ARV regimens and comparators, and for their babies.
Read the detailed description
A total of 44 late-presenters (gestational age >28 weeks), HIV-infected pregnant women will be randomly assigned to receive an antiretroviral regimen based on Zidovudine (AZT)+Lamivudine (3TC)+Raltegravir or AZT+3TC+Lopinavir/r (LPV/r). They will be followed up to the delivery, and plasma viral load will be measured. The rate of HIV mother-to-child-transmission will be compared between groups. The newborns will be followed up to 6 months, to register any adverse event during this period of time.
- Being tested
- Raltegravir, Lopinavir/Ritonavir
- Keywords
- HIV, Treatment, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
a raltegravir-based antiretroviral regimen (AZT+3TC+Raltegravir) will be administered for intervention arm patients (AZT+3TC will be administered in a fixed combination of AZT 300mg +3TC 150 mg, BID. Raltegravir will be administered in a dosis of 1 400 mg pill BID).
Lopinavir/RitonavirDrug
Also called Kaletra
The second arm (comparator)patients will use a regimen composed by AZT+3TC (same dosis/schedule of active arm)+ LPV 200mg combined with rtv 50 mg, 2 pills BID
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | Use of Raltegravir plus backbone treatment for pregnant women Receives: Drug: Raltegravir |
| Lopinavir/Ritonavir | Active comparator | Use of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women Receives: Drug: Lopinavir/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Viral Load at Delivery
Number of participants presenting with PVL<50 copies/mL at delivery
Measured: 2, 4, 6 weeks and at delivery
Secondary outcomes (2)
Overall Adverse Events up to Delivery
Frequency of clinical and laboratory abnormalities by arm
Measured: 2, 4, 6 weeks and at delivery
Number of Children Infected With HIV
Detectable plasma HIV-1 RNA viral load at 4 weeks after delivery
Measured: 4 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study start1 Jun 2015
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Why it stopped: IRB recommended study termination due to a significant difference between arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized single-center open label clinical trial
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Bahiana de Infectologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Brites, Fundação Bahiana de Infectologia
- Investigators
- Carlos Brites, MD, PhD, Principal investigator, Fundação Bahiana de Infectologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854762
- Sponsor's protocol ID
- PregnantHIV
- Acronym
- PregnantHIV
- Status last verified
- Sep 2024
- First submitted
- 22 Apr 2013
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data regarding the protocol will be made freely available at the website of Fundação Bahiana de Infectologia.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection in Pregnant Women Presenting With Detectable Viral Load After 32 Weeks of Gestation: a Pilot Study
- ClinicalTrials.gov ID
- NCT01854762
- Acronym / sponsor ID
- PregnantHIV / PregnantHIV
- Keywords
- HIV, Treatment, Pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB recommended study termination due to a significant difference between arms
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fundação Bahiana de InfectologiaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failure to ARV drugs of different classes. However, some problems are still present, especially for specific populations, like pregnant women and infants. For these groups, most of currently available drugs are not used, because the lack of information on safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child transmission (MTCT) is still a problem in certain areas of the world, especially in resource-limited settings. In some settings, women often present to their first antenatal care visit late in the pregnancy, posing an additional problem: how to effectively treat these patients to assure they will have an undetectable viral load at the moment of delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6 or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA / ml of plasma. To achieve this goal, it would be necessary the use of a potent, very efficacious ARV regimen that could provide such viral decay in a very short period. Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it has no genotoxic potential, and promotes a rapid decline in HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to be used for prevention of MTCT for women with detectable viral load, presenting late in the course of pregnancy. Another attractive point is to consider that, due to the similarity between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1); RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct, the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1 RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters pregnant women and to compare the frequency of adverse events for women using RAL-based ARV regimens and comparators, and for their babies.
Detailed description
A total of 44 late-presenters (gestational age >28 weeks), HIV-infected pregnant women will be randomly assigned to receive an antiretroviral regimen based on Zidovudine (AZT)+Lamivudine (3TC)+Raltegravir or AZT+3TC+Lopinavir/r (LPV/r). They will be followed up to the delivery, and plasma viral load will be measured. The rate of HIV mother-to-child-transmission will be compared between groups. The newborns will be followed up to 6 months, to register any adverse event during this period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized single-center open label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: RaltegravirUse of Raltegravir plus backbone treatment for pregnant women |
| Lopinavir/Ritonavir | Active comparator | Drug: Lopinavir/RitonavirUse of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
- Gestational age higher than 28 weeks
- Age equal or higher than 15 years
- HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml
Key exclusion criteria (3 listed)
- Age lower than 15 years
- Undetectable plasma viral load at screening
- Previous use of RAL
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 |
|---|---|---|
| RaltegravirAlso: Isentressa raltegravir-based antiretroviral regimen (AZT+3TC+Raltegravir) will be administered for intervention arm patients (AZT+3TC will be administered in a fixed combination of AZT 300mg +3TC 150 mg, BID. Raltegravir will be administered in a dosis of 1 400 mg pill BID). | Drug | Raltegravir |
| Lopinavir/RitonavirAlso: KaletraThe second arm (comparator)patients will use a regimen composed by AZT+3TC (same dosis/schedule of active arm)+ LPV 200mg combined with rtv 50 mg, 2 pills BID | Drug | Lopinavir/Ritonavir |
Primary outcome
HIV Viral Load at Delivery
Time frame: 2, 4, 6 weeks and at delivery
Number of participants presenting with PVL<50 copies/mL at delivery
2 secondary outcomes
Overall Adverse Events up to Delivery
Time frame: 2, 4, 6 weeks and at delivery
Number of Children Infected With HIV
Time frame: 4 weeks after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data regarding the protocol will be made freely available at the website of Fundação Bahiana de Infectologia.
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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.
Carlos Brites, MD, PhD principal investigator
Fundação Bahiana de Infectologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Raltegravir and Lopinavir/Ritonavir in people with HIV and Pregnancy, run by Fundação Bahiana de Infectologia at 1 site in Brazil.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Oct 2024. 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 Brazil. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HIV Viral Load at Delivery (time frame: 2, 4, 6 weeks and at delivery). 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 15 Oct 2024.