Phase 2
Completed N=175
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
Source: ClinicalTrials.gov NCT00109590 ↗Enrolled (actual)
175
Serious AEs
30.1%
Results posted
Nov 2012
Primary outcomePrimary: The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum). — 7.1; 12.5; 5.3 percent of participants
Summary
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir/ritonavir (LPV/r) will also be studied.
Study hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum). |
7.1; 12.5; 5.3 | — |
| PRIMARY The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma |
3.6; 7.1; 5.3 | — |
| PRIMARY Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL) |
99.7; NA | 0.009 sig |
| PRIMARY Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) . |
11.2; NA | — |
| PRIMARY Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL). |
6.08; 9.17 | — |
| PRIMARY Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL). |
10.78; 12.96 | — |
| SECONDARY The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry |
4.9; 9.5; 7.0 | — |
| SECONDARY The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations. |
0; 1.78; 0; 0; 0; 0 | — |
| SECONDARY Number of Women With Grade >=3 Events After Start of Study Treatment |
2; 0; 2 | — |
| SECONDARY Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum. |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Resistance Mutations in HIV Infected Infants |
0; 0 | — |
| SECONDARY Median HIV-1 Viral Load at 24 Weeks Postpartum in Women |
4.3; 3.9; 4.0 | — |
Eligibility Criteria
Inclusion Criteria for Mothers:
- HIV infected
- Pregnant with a viable fetus
- Between 28 and 38 weeks of pregnancy
- CD4 count greater than 250 cells/mm3 within 30 days prior to study entry
- Able to receive oral ART during labor
- Willing to use acceptable forms of contraception while on study treatment
- Able to provide written informed consent
Exclusion Criteria for Mothers:
- Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV
- Any ART other than ZDV during a previous pregnancy or the current pregnancy
- Certain medications
- Planning to receive additional ART during the first 8 weeks postpartum
- Planning to breastfeed
- Unlikely to comply with postpartum study requirements, in the opinion of the investigator
- Certain abnormal laboratory values within 30 days prior to study entry
Data sourced from ClinicalTrials.gov (NCT00109590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.