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| Sponsor: | French National Agency for Research on AIDS and Viral Hepatitis |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00424814 |
Purpose
In the pre-partum phase the use of antiretroviral therapy for the mother during the last trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate toxicities related to both families. The aim of this study is to assess the use of a boosted protease inhibitor without nucleoside analogue during the pre-partum phase for women with no indication of antiretroviral therapy for their own.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Kaletra (lopinavir/ritonavir) Drug: Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine) |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-Partum Phase. A Multicenter Randomised Phase II/III Open Label Study With a Group of 100 Pregnant Women Receiving Lopinavir/Ritonavir and a Group of 50 Receiving Lopinavir/Ritonavir Plus Zidovudine and Lamivudine. ANRS 135 Primeva |
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Kaletra (lopinavir/ritonavir)
|
Drug: Kaletra (lopinavir/ritonavir)
(200/50 mg x2)x 2/d= 2 pills twice daily
|
|
2: Active Comparator
Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)
|
Drug: Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)
Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily
|
Recent data from the French perinatal cohort and others indicate that HIV-RNA levels at delivery correlate with risk of transmission among women treated with antiretroviral agents. Most of these treatments include zidovudine alone or in combination. Mitochondrial toxicity related to nucleoside analogues exposure (zidovudine and lamivudine) has been reported in adults and in infants with in utero exposure to these drugs. In addition, biological markers of genotoxicity on nuclear DNA have recently been shown in exposed newborn. These issues raised the concern of the risk/benefit of multiple therapy in the context of mother to child transmission for women who do not meet the standard criteria for antiretroviral therapy. In women with CD4≥350 and VL<30 000 copies/ml a treatment with lopinavir/ritonavir should achieve a rapid control of HIV1 viremia below 1000 copies/ml without harm in term of resistance. In this study we would like to assess under strict control, the safety and efficacy of such regimen compared to the same boosted PI + zidovudine and lamivudine as standard regimen. The treatment will start at 26 weeks of gestation, and the follow up will include safety and efficacy parameters as well as pharmacokinetics in plasma and genital tract for the women, blood/cord ratio, testing for ARV resistance. Women will stop their treatment after delivery. Infants will be closely monitored up to 24 months with HIV DNA and HIV.RNA-PCR for HIV testing and biochemical and haematology usual safety evaluation. In addition frozen samples will be collected for specific evaluation of nucleoside analogue foetal mitochondrial and nuclear DNA interactions.
In term of transmission safety, the end point would be to reach a viral load below 200 copies after 8 weeks of treatment. In case of failure, this would allow a sufficient delay for a treatment modification: i.e. addition of NRTI and an elective caesarian could be programmed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Assessed between 20 and 24 months of pregnancy
Exclusion Criteria:
Contacts and Locations| Contact: Sandrine Delmas, MD | 33 1 49 59 53 16 | delmas@vjf.inserm.fr |
| France | |
| Hopital Pitie salpetriere | Recruiting |
| Paris, France, 75013 | |
| Contact: Roland Tubiana, MD 33 1 42 16 01 71 roland.tubiana@psl.ap-hop-paris.fr | |
| Principal Investigator: | Roland Tubiana, MD | AP-HP Hopital Pitie salpetriere |
| Study Chair: | Josiane Warszawski, MD | INSERM - INED Unité U822 France |
More Information
| Responsible Party: | ANRS ( MJ Commoy/ regulatory affairs sponsor ) |
| Study ID Numbers: | 2006-006200-11, ANRS 135 PRIMEVA |
| Study First Received: | January 19, 2007 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00424814 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
HIV mother to child prevention HIV Infections Kaletra Combivir HIV Seronegativity |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Lopinavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |
