Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
- Conditions
- Health Condition 1: null- HIV positive pregnant women,
- Registration Number
- CTRI/2018/02/011794
- Lead Sponsor
- ational Institute of Allergy and Infectious Diseases NIAIDMaryland USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method