Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
In the prospective cohort study (Part I), there will be two groups of women:
Group A: Women who meet WHO criteria for HAART, i.e. CD4+ cell counts below 200 cells/mm^3 or with stage four HIV disease,
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant, with a gestational age of 28 - 34 weeks (or between 16 and 32 weeks gestation if the woman is referred with medically-documented HIV stage four [clinical AIDS] or CD4+ cell count below 200 cells/mm^3 diagnosed before study screening) 2. No evidence of clinically-significant conditions likely to require specific care arrangements and which may interfere with study interventions (obstetric, cardiac, respiratory [including active tuberculosis], hepatic, gastrointestinal, endocrine, renal, haematologic, psychiatric, neurologic, or allergic) as assessed by the study site Principal Investigator 3. Confirmation of HIV infection at the study site 4. Not having received an HIV vaccine (never enrolled in an HIV-vaccine trial) 5. Willingness to receive, and no contraindication to receive, the short MTCT-prophylaxis regimen as a minimum 6. No previous enrolment in the Kesho Bora study 7. Capacity and willingness to participate in all follow-up visits, including participating in all clinical examinations, having blood drawn, as well as willingness for their infant to be clinically and physically examined and have blood drawn 8. Residing, and planning to continue to reside, within a predefined, site-specific catchment area until two years after delivery 9. Ability and willingness to give informed consent for enrolment in the study 10. Not currently taking Anti-RetroViral drugs (ARV) drugs Women who meet the above eligibility criteria will be invited to enrol in the study (Part I). Those who, in addition, meet WHO criteria for initiating HAART, have no contraindications to HAART and accept HAART will be enrolled in Part IA and will receive HAART. All other women will be enrolled in Part IB and will receive the short-course MTCT prophylaxis. This includes women not meeting WHO criteria for treatment, having a contraindication to HAART, or refusing HAART. Additional eligibility criteria for women in Part IB to be enrolled in the randomised controlled trial (Part II) are: 1. Not meeting WHO clinical criteria for treatment 2. Having CD4+ cell count between 200 and 500 cells/mm^3 3. Having no contraindication to the triple-ARV MTCT-prophylaxis regimen 4. Willing to be randomised to receive the triple-ARV or short-course MTCT-prophylaxis regimen
Exclusion criteria
Exclusion criteria: Does not comply with the inclusion criteria above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HIV-free infant survival at 6 weeks and 12 months 2. AIDS-free survival among mothers by 12 months postpartum 3. Incidence of severe adverse events in mothers | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the RCT are to: 1. Assess HIV-free survival at birth, 2 weeks, 6 weeks, 6 months, 9 months (a point when all breast feeding is likely to have ceased) and 12 months of age among all enrolled children 2. Estimate the rates of early and late postpartum transmission in ever breastfed infants, according to maternal HIV status and treatment received 3. Describe the correlates of infant HIV-free survival including stage of maternal HIV disease (clinical, immunological and virological factors), ARV prophylaxis and/or therapy given to the mother, and mode of infant feeding 4. Describe the correlates of mother?s HIV disease progression and survival including socio-demographic characteristics, disease and nutritional status at enrolment, ARV prophylaxis and/or therapy given to the mother, and mode of infant feeding 5. Identify immunological and virological determinants of residual HIV-1 transmission during breastfeeding (coordinated by P. Van de Perre through ANRS1271 programme) 6. Describe and compare the feasibility, acceptability, safety, tolerability of and adherence to the maternal ARV prophylaxis 7. Describe the feasibility and acceptability of current UNAIDS/UNICEF/WHO recommendations on HIV and infant feeding (coordinated by K. Simondon through ANRS1271 programme) 8. Assess the feasibility and safety of rapid weaning over a two week period with complete cessation of breastfeeding by 6 months of age, and assess nutritional status and growth of children up to two years of age (coordinated by K. Simondon through ANRS1271 programme) 9. Describe changes in viral load and emergence of viral resistance in blood and breast milk according to the maternal ARV prophylaxis and therapy regimens and immunological and virological status at enrolment 10. Describe the extent of partner involvement, family planning practices, condom use and sexual activity of couples 11. Describe and analyse the social and cultural factors that may increase or reduce HIV rat | — |
Countries
Burkina Faso, Kenya, South Africa
Outcome results
None listed