Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection (PregnantHIV)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Fundação Bahiana de Infectologia
Sponsor:
Information provided by (Responsible Party):
Carlos Brites, Fundação Bahiana de Infectologia
ClinicalTrials.gov Identifier:
NCT01854762
First received: April 22, 2013
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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 HTLV; 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.


Condition Intervention Phase
HIV
Pregnancy
Drug: Raltegravir
Drug: Lopinavir/Ritonavir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundação Bahiana de Infectologia:

Primary Outcome Measures:
  • HIV Viral load at delivery [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall adverse events at delivery [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Number of children infected with HIV [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir
Use of Raltegravir plus backbone treatment for pregnant women
Drug: Raltegravir
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).
Active Comparator: Lopinavir/Ritonavir
Use of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women
Drug: Lopinavir/Ritonavir
The second arm (comparator)patients will use a regimen composed by AZT+3TC (same dosis/schedule of active arm)+ LPV 200mg coformulated with rtv 50 mg, 2 pills BID

Detailed Description:

A total of 44 late-presenters (gestational age >32 weeks), HIV-infected pregnant women will be randomly assigned to receive an antiretroviral regimen based on AZT+3TC+Raltegravir or AZT+3TC+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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
  • Gestational age higher than 32 weeks
  • Age equal or higher than 18 years
  • HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

  • Age lower than 18 years
  • Undetectable plasma viral load at screening
  • Previous use of RAL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854762

Contacts
Contact: Estela Luz, RN, MSci 32838123 eluz5@yahoo.com.br

Locations
Brazil
Fundação Bahiana de Infectologia/SEI Not yet recruiting
Salvador, Bahia, Brazil, 40110-010
Contact: Estela Luz, RN, MSci    32838123    eluz5@yahoo.com.br   
Sub-Investigator: Ana Gabriela A Travassos, MD, MSci         
Sub-Investigator: Isabela Nobrega, MD, MSci         
Sponsors and Collaborators
Fundação Bahiana de Infectologia
Investigators
Principal Investigator: Carlos Brites, MD, PhD Fundação Bahiana de Infectologia
  More Information

No publications provided

Responsible Party: Carlos Brites, Senior Investigator, Fundação Bahiana de Infectologia
ClinicalTrials.gov Identifier: NCT01854762     History of Changes
Other Study ID Numbers: PregnantHIV
Study First Received: April 22, 2013
Last Updated: May 13, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Fundação Bahiana de Infectologia:
HIV
Treatment
Pregnancy

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014