Health Condition 1: null- HIV positive pregnant women,
Conditions
Interventions
Intervention1: Drug: Emtricitabine/tenofovir disoproxil fumarate: 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily
Sponsors
National Institute of Allergy and Infectious Diseases NIAIDMaryland USA
Johns Hopkins University USA Baltimore
Eligibility
Inclusion criteria
Inclusion criteria: 1 HIV infected 2 CD4 count 250 cells/mm3 or greater within 30 days of study entry 3 Pregnant with a viable fetus at 28 to 38 weeks of pregnancy 4 Willing to give birth to baby in a hospital or clinic
Exclusion criteria
Exclusion criteria: 1 Any ART, including single-dose NVP, prior to study entry. 2 Mothers who receive ZDV monotherapy prior to labor under the supervision of the site investigator are not excluded. 3 Known allergy or sensitivity to study drugs or their formulations 4 Current drug or alcohol abuse that may interfere with the study 5 Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded. 6 Hepatitis B surface antigen positive within 180 days prior to study entry 7 Active tuberculosis infection requiring treatment 8 Prior enrollment in this study 9 Expect to use ART, except ZDV monotherapy, prior to onset of labor 10 Expect to use ART other than study medications from delivery to 9 weeks postpartum 11 Require certain medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants found to have prolonged exposure to suboptimal NVP concentrations due to long plasma half-life of NVP will be at greater risk of development of NVP mutations.transcriptase inhibitor (NNRTI)-resistant variants as detected by standard composite (bulk) genotyping [ Time Frame: Throughout study ] [ Designated as safety issue: No ] Timepoint: 7 or 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: ?Proportion of participants with new circulating NRTI- and new PI- resistant variants [ Time Frame: Throughout study ] [ Designated as safety issue: No ] ?Proportion of participants with new circulating NNRTI-, NRTI-, or PI- resistant virus [ Time Frame: Through Week 24 ]Timepoint: week 24 | — |
Countries
India, South Africa
Contacts
Public ContactDr Nishi Suryavanshi
B. J Medical College CTU
Outcome results
None listed