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Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
Phase 4 trial testing Lamivudine/zidovudine in HIV Infections in 408 participants. Completed in 11 December 2018.
| Lead sponsor | Westat |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 408 |
| Start date | 5 September 2013 |
| Primary completion | 11 December 2018 |
| Estimated completion | 11 December 2018 |
| Sites | 19 locations across South Africa, Tanzania, Argentina, Puerto Rico, Thailand, United States, Brazil |
Westat — full company profile →
16 and older, female only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .84 | |
| Arm B (Women) | .94 |
Only women who initiated (i.e. received at least one dose of) their randomized treatment were eligible for this outcome measure. Women were considered to have discontinued study drug if they stopped receiving efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason, including loss to follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .05 | |
| Arm B (Women) | .03 |
"New" adverse events were those with an onset date on or after randomization. Adverse events present at baseline would only be considered "New" if they increased in grade on or after randomization. All women who received at least one dose of study drug were eligible for this analysis.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .30 | |
| Arm B (Women) | .30 |
All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Infants) | .25 | |
| Arm B (Infants) | .25 |
A successful outcome was defined as maternal HIV-1 RNA plasma viral load less than the lower limit of quantification (LLQ) for the testing assay, which could vary. Most (99%) women had their viral load measured using an assay with LLQ equal to 40 or 20 copies/mL. If the viral load at delivery was missing, the last observed viral load within 21 days prior to the delivery date was considered.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .58 | |
| Arm B (Women) | .86 |
A successful viral load decrease was defined as follows: for women having HIV-1 RNA viral load greater than or equal to 10,000 copies/mL at entry, a viral load \<200 copies/mL; for women with VL less than 10,000 copies/mL at entry, a Log10 viral load decrease of at least 2.0 from entry.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .63 | |
| Arm B (Women) | .89 |
Change in viral load from entry (or screening, if there was no entry viral load) to each study week prior to delivery, calculated on the log10 scale as log10(week X RNA) - log10(baseline RNA). For this analysis, HIV-1 RNA values that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -1.4 | -1.7 – -1.2 |
| Arm B (Women) | -1.5 | -1.8 – -1.2 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -1.8 | -2.0 – -1.4 |
| Arm B (Women) | -2.1 | -2.4 – -1.6 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -2.0 | -2.3 – -1.6 |
| Arm B (Women) | -2.4 | -2.8 – -1.6 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -2.1 | -2.5 – -1.7 |
| Arm B (Women) | -2.4 | -3.0 – -1.7 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -2.2 | -2.6 – -1.7 |
| Arm B (Women) | -2.4 | -3.0 – -1.7 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -2.3 | -2.7 – -1.8 |
| Arm B (Women) | -2.3 | -3.0 – -1.7 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -2.4 | -2.7 – -1.9 |
| Arm B (Women) | -2.5 | -3.0 – -1.8 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | -2.5 | -2.6 – -1.9 |
| Arm B (Women) | -2.5 | -3.0 – -1.8 |
The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose).
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .75 | |
| Arm B (Women) | .95 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .85 | |
| Arm B (Women) | .96 |
The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). Vaginal swabs produce much less testable sample volume than blood plasma draws. Each vaginal swab specimen had to be diluted, and this dilution factor raised the lower limit of quantification (LLQ). The most commonly observed LLQs were 300 and 1200. For consistency, the higher LLQ was considered the threshold for this outcome measure.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .97 | |
| Arm B (Women) | .95 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .98 | |
| Arm B (Women) | .94 |
The unit of analysis was the mother-infant set. All sets where the woman received at least one dose of study treatment and remained on study through delivery were eligible. In the case of twins, the worst outcome (i.e. a stillbirth) was used.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .005 | |
| Arm B (Women) | .015 |
The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having a premature delivery if any infant in the mother-infant set was delivered prior to 37 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 37 weeks gestation then this set would count as one premature delivery outcome). All mother-infant sets that delivered at least one live birth on study were eligible for this outcome.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .105 | |
| Arm B (Women) | .123 |
The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having an extremely premature delivery if any infant in the mother-infant set was delivered prior to 34 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 34 weeks gestation then this set would count as one extremely premature delivery outcome). Only women who enrolled prior to 34 weeks gestation were included in this analysis. Those that enrolled from 34 to less than 37 weeks gestation were excluded because they were already past the gestational a
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Women) | .036 | |
| Arm B (Women) | .023 |
Time frame: Adverse event data were collected from entry (20-36 weeks gestation) through delivery for women. Additionally, both women and infants had adverse event data collected from delivery through their final study visit which was scheduled to occur at Week 24 postpartum.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Women) | Arm B (Women) | Arm A (Infants) | Arm B (Infants) |
|---|---|---|---|---|---|
| Congenital syphilis | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Atrial septal defect | Congenital, familial and genetic disorders | — | — | — | — |
| Premature baby | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Sepsis neonatal | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Transient tachypnoea of the newborn | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Premature labor | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Umbilical hernia | Gastrointestinal disorders | — | — | — | — |
| Ankyloglossia | Congenital, familial and genetic disorders | — | — | — | — |
| Foetal death | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Congenital skin dimples | Congenital, familial and genetic disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| ABO incompatibility | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Reaction | System | Arm A (Women) | Arm B (Women) | Arm A (Infants) | Arm B (Infants) |
|---|---|---|---|---|---|
| Haemoglobin decreased | Investigations | — | — | — | — |
| Congenital syphilis | Congenital, familial and genetic disorders | — | — | — | — |
Most-reported serious reactions: Congenital syphilis, Foetal distress syndrome, Hypertension, Atrial septal defect, Premature baby, Sepsis neonatal, Anaemia, Postpartum haemorrhage.
Data from ClinicalTrials.gov NCT01618305 adverse events section.
HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late stages of pregnancy need an effective medication regimen to reduce the risk of transmitting HIV to their children. This study examined the virologic response, safety, and tolerability of two different ARV medication regimens in HIV-infected pregnant women who were between 20 and 36 weeks pregnant when they entered the study.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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