HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV Nearly Naive

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-007-08
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• HIV-1 infection. documented by an officially authorized HIV ELISA Test and confirmed by a Western Blot at some time prior to the start of the study. Culture of HIV, HIV-1 antigen, HIV-1 plasma RNA or a second antibody test by a method other than ELISA is accepted as an alternative confirmatory test.
• ViH-1 plasmatic RNA of ^ 500 copies / mL measured with the Roche UltraLensensitive Roche Amplicor Monitor assay (Roche Molecular Systems) and performed within 90 days prior to patient admission in an approved DAIDS laboratory.
• Women> 16 years old.
• Previous history of ART in combination for> 7 days during at least one pregnancy for HIV pMTCT.
• ART history only for the purpose of pMTCT for a maximum of 40 weeks during pregnancy and 12 weeks postpartum for each pregnancy and with an interval between pregnancies of at least 24 weeks without treatment.
• Clinical or laboratory indication (such as drop in CD4 + count) to initiate ART in the opinion of the participant´s health care provider.
• Successful genotyping of the screening plasma sample within 90 days prior to study entry.
• Potentially fertile women participants, defined as girls who have reached menarche, women who are not post-menopausal for at least 24 months, or have not undergone a surgical sterilization procedure (hysterectomy or bilateral oophorectomy, or bilateral salpogectomy or ligature tubaria) must have a negative serum or urine pregnancy test done within 2 days before entering the study.
• Ability and availability on the part of the candidate or legal representative / guardian to sign the Informed Consent form.

Exclusion Criteria

• Have received an ARV in the 24 weeks prior to the start of the study.
• Evidence of any of the mutations for HIV-1 RT within 90 days prior to the start of the study [36]: NNRTI-associated mutations: LOOOO, K103N, V106A / M, V108I, Y181C / 1, Y188C / H / L, G190A / S, P225H, P236L Mutations associated with NRTi: M41L, K65R. D67N, insertion complex 69, K70R, L74V, Q151M, M184V, L210W, T215A / C / D / E / F / G / H / 1 / L / N / SA // Y, K219Q / E, Y115F.
• Evidence of any of the mutations listed in 4.2.2 in a standard viral resistance test for majority populations obtained at any time before the start of the study (if available).
• Treatment for pMTCT with sd-NVP, inclusion of NVP as a simple agent in a regimen that is failing or adding some component of the regimen used in A5227 as a simple agent to a regimen that is failing. Failure is defined as an increase in viral load above> 0.5 log10 of baseline or loss of suppression (> 200 copies / mL) of plasma HIV-1 RNA.
• Treatment within 14 days prior to the start of the study
• Use of vaccines for HIV, chronic systemic corticosteroids, interleukins, interferon, other cytokines or research therapies within 30 days prior to the start of the study.
• Acute therapy for serious medical conditions (in the opinion of the investigator) within 14 days prior to the start of the study unless the study participant has completed 7 days of therapy and is clinically stable.
• Any condition which, in the opinion of the researcher, may compromise the participant´s ability to participate in the study.
• Malignities that require systemic chemotherapy.
• Allergy / known sensitivity to one or the study drugs or their formulations.
• Pregnancy and lactation.
• Use of drugs or alcohol that, in the opinion of the investigator, could interfere with the adherence to the requirements of the study.
• Documentation of 2 VlH-1 RNAs> 5,000 consecutive copies / mL 8 weeks or more after initiating ART during pregnancy and while receiving ART.
• Documentation of 2 HIV-1 RNAs> 400 consecutive copies / mL 24 weeks or more after initiating ART during pregnancy and while receiving ART.
• Current incarceration or placement in a medical center due to psychiatric or physical illness (eg, infectious disease).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:measured as <200 copies / mL of HIV-1 plasma RNA<br>in week 24.<br>Measure:Virological response<br>Timepoints:week 24.<br>