| Publications: | A Guide to the Clinical Care of Women with HIV/AIDS, 2005 edition |
| Site/Sponsor | Antepartum | Intrapartum | Post-partum Mother | Post-partum Infant | Results |
|---|---|---|---|---|---|
| US (PACTG 076) •Randomized, placebo-controlled •Formula feeding •N=477 |
Starting at 14-34 wks Arm 1: ZDV 100 mg 5x/d Arm 2: Placebo |
Arm 1: ZDV intravenous infusion Arm 2: Placebo |
No ARV | Arm 1: ZDV 2 mg/kg qid x 6 wk Arm 2: Placebo |
•At 18 mo, tx 7.6% ZDV vs 22.6% placebo, 68% efficacy (Connor, 1994) |
| THAILAND (CDC) •Randomized, placebo-controlled •Formula feeding •N=392 |
Starting at 36 wks Arm 1: ZDV 300 mg bid Arm 2: Placebo |
Arm 1: ZDV 300 mg q 3 hr Arm 2: Placebo |
No ARV | No ARV | •At 6 mos, tx 9.4% ZDV vs 18.9% placebo, 50% efficacy (Shaffer, 1999) |
| IVORY COAST (CDC) •Randomized, placebo-controlled •Breastfeeding •N=280 |
Starting at 36 wks Arm 1: ZDV 300 mg bid Arm 2: Placebo (stopped 2/98) |
Arm 1: ZDV 300 mg q 3 hr Arm 2: Placebo (stopped 2/98) |
No ARV | No ARV | •At 3 mos, tx 16.5% ZDV vs 26.1% placebo, 37% efficacy (Wiktor, 1999) |
| IVORY COAST/BURKINA FASO (DITRAME; ANRS 049a) •Randomized, placebo-controlled •After trial completion, continued to enroll into an open-label ZDV regimen cohort •Breastfeeding •N=400 |
Starting at 36-38 wks Arm 1: ZDV 300 mg bid Arm 2: Placebo (stopped 2/98) |
Arm 1: ZDV 600 mg x1 Arm 2: Placebo (stopped 2/98) |
Arm 1: ZDV 300 mg bid x 1 wk Arm 2: Placebo (stopped 2/28) |
No ARV | •At 6 mos, tx 18.0% ZDV vs 27.5% placebo, 38% efficacy •At 15 mos, tx 21.5% ZDV vs 30.6% placebo, 30% efficacy •At 24 mos (pooled analysis with CDC), tx 22.5% ZDV vs 30.2% placebo, 26% efficacy •18 mo mortality: 17.6% ZDV vs 22.1% placebo •Open-label ZDV cohort (N=209), 15 mo tx with ZDV regimen, 19.6% (Dabis, 1999; DITRAME ANRS 049 Study Group, 1999; Leroy, 2002) |
| THAILAND/PHPT (Harvard) •Randomized, comparative, factorial •No placebo (076-like control) •Formula feeding •N=1,437 |
ZDV 300 mg bid Arm 1 (Long-Long, LL): 28 wks Arm 2 (Long-Short, LS): 28 wks Arm 3 (Short-Long, SL): 36 wks Arm 4 (Short-short, SS): 36 wks |
ZDV 300 mg q 3 hr Arm 1: Oral Arm 2: Oral Arm 3: Oral Arm 4: Oral |
No ARV | ZDV 2 mg/kg qid Arm 1: 6 wks Arm 2: 3 d Arm 3: 6 wks Arm 4: 3 d |
•Interim analysis 3/99 (N=449 enrolled), stopped SS arm due to sig higher tx than LL, — At 6 mos, tx 10.5% SS vs 4.1% LL •Final analysis 7/00, no sig differences; — At 6 mos, tx 6.5% LL vs 4.7% LS vs 8.6% SL •In utero tx sig different: — 1.6% [LL+LS] vs 5.1% [SL+SS] (Lallemant, 2000) |
| SOUTH AFRICA, UGANDA, TANZANIA (PETRA) •Randomized, placebo-controlled •Breastfeeding •N=1,797 |
Starting at 36 wks Arm 1: ZDV 300 mg bid plus 3TC 150 mg bid Arm 2: Placebo Arm 3: Placebo Arm 4: Placebo (stopped 2/98) |
|
Arm 1: ZDV 300 mg bid plus 3TC 150 mg bid x 7 d Arm 2: ZDV 300 mg bid plus 3TC 150 mg bid x 7 d Arm 3: Placebo Arm 4: Placebo (stopped 2/98) |
Arm 1: ZDV 4 mg/kg bid plus 3TC 2 mg/kg bid x 7 d Arm 2: ZDV 4 mg/kg bid plus 3TC 2 mg/kg bid x 7 d Arm 3: Placebo Arm 4: Placebo (stopped 2/98) Petra Study Team |
•At 6 wks, tx: — 5.7% AP/IP/PP (63% efficacy) — 8.9% IP/PP (42% efficacy) — 14.2% IP — 15.3% placebo •At 18 mos, tx: — 14.9% AP/IP/PP — 18.1% IP/PP — 20.0% IP — 22.2% placebo (Petra Study Team, 2002) |
| FRANCE (ANRS 075) •Non-randomized, open-label •Formula feeding •N=445 |
Standard ZDV after 14 wks 3TC 150 mg bid added at 32 wks |
Standard intravenous ZDV | Non-study ARV | Standard ZDV x 6 wks 3TC 2 mg/kg bid x 6 wks |
•Tx 1.6% ZDV/3TC vs 6.8% 1994-97 historical, ZDV-alone control (Mandelbrot, 2001) |
| THAILAND (Ministry of University Affairs, Bangkok) •Non-randomized, open-label •Formula feeding •N=106 |
Starting at 34 wks ZDV 300 mg bid plus 3TC 150 mg bid |
ZDV 300 mg q 3 hr plus 3TC 150 mg q 3 hr |
No ARV |
ZDV 2 mg/kg qid x 4 wks |
•At 18 mos, tx 2.8% vs 11.7% historical, ZDV-alone control (N=60: 36 wk start, oral IP, 4 wk infant) (Chaisilwattana, 2002) |
| UGANDA (HIVNET 012) •Randomized; originally had 3rd placebo arm, stopped 2/98 •Breastfeeding •N=626 |
Arm 1: No ARV Arm 2: No ARV Arm 3: No ARV |
Arm 1: NVP 200 mg x1 Arm 2: ZDV 300 mg q 3 hr Arm 3: Placebo (stopped 2/98) |
No ARV | Arm 1: NVP 2 mg/kg x 1 at 48-72 hr Arm 2: ZDV 4 mg/kg bid x 7 d Arm 3: Placebo (stopped 2/98) |
•At 14-16 wks, tx 13.1% NVP vs 25.1% ZDV, 47% efficacy •At 18 mos, tx 15.7% NVP vs 25.8% ZDV, 41% efficacy (Guay, 1999) |
| US/EUROPE/BRAZIL/ BAHAMAS (PACTG 316) •Randomized, [NVP] placebo-control •Women and infants received non-study standard ARV •Formula feeding •N=1,248 |
Non-study ARV (23% ZDV alone, 36% combo without PI, 41% combo with PI) |
Standard intravenous ZDV Arm 1: NVP 200 mg x 1 Arm 2: Placebo |
Non-study ARV | Standard ZDV (with or without other ARV) x 6 wks Arm 1: NVP 2 mg/kg x 1 at 48-72 hr Arm 2: Placebo |
•Stopped early due to low 1.5% overall tx (53% in utero) •At 6 mos, tx 1.4% NVP vs 1.6% placebo (Dorenbaum, 2002) |
| SOUTH AFRICA (SAINT) •Randomized, comparative •Breastfeeding (42%) and formula feeding •N=1,331 |
Arm 1: No ARV Arm 2: No ARV |
Arm 1: NVP 200 mg x1 Arm 2: ZDV 600 mg then 300 mg q 3 hr plus 3TC 150 mg q 12 hr |
Arm 1: NVP 200 mg x 1 at 24-48 hr Arm 2: ZDV 300 mg bid plus 3TC 150 mg bid x 7 d |
Arm 1: NVP 6 mg x 1 at 24-48 hr (>2kg) Arm 2: ZDV 12 mg bid plus 3TC 6 mg bid x 7 d (>2 kg) |
•At 8 wks, tx 12.3% NVP vs 9.3% ZDV/3TC (p=0.11) (Moodley, 2003) |
| THAILAND (CDC) •Non-randomized, open-label •Formula feeding •N=195 |
Starting at 34-36 wks ZDV 300 mg bid |
ZDV 300 mg q3 hrs plus NVP 200 mg x1 |
No ARV |
ZDV 2 mg/kg qid x 4 wks plus NVP 6 mg x 1 at 48-72 hr |
•Tx 4.6% (Chalermchokcharoenkit, 2004) |
| THAILAND/PHPT (Harvard) •Randomized, comparative •All women/infant get short-course ZDV •Formula feeding •N=1,844 |
Starting at 28 wks Arm 1: ZDV 300 mg bid Arm 2: ZDV 300 mg bid Arm 3: ZDV 300 mg bid |
Arm 1: ZDV 300 mg q 3 hr Arm 2: ZDV 300 mg q 3 hr plus NVP 200 mg x 1 Arm 3: ZDV 300 mg q 3 hr plus NVP 200 mg x 1 |
No ARV | Arm 1: ZDV 2 mg/kg qid x 7 d Arm 2: ZDV 2 mg/kg qid x 7 d Arm 3: ZDV 2 mg/kg qid x 7 d plus NVP 6 mg x 1 at 48-72 hr |
•Interim analysis 6/02: --ZDV alone Arm 1 stopped due to higher tx than in ZDV/NVP Arm 3 •Analysis through 3/03: --ZDV alone 6.3% --Arms 2 & 3 combined 1.7% --NVP/placebo 2.8% --NVP/NVP 1.9% (Lallemant, 2004) |
| MALAWI (Fogarty) •Randomized, comparative •Designed for infants of women 1st identified as HIV+ in labor/PP •Breastfeeding •N=1,119 |
No ARV | No ARV | No ARV | Arm 1: NVP 2 mg/kg x 1 at 48-72 hr Arm 2: NVP 2 mg/kg x 1 at 48-72 hr plus ZDV 4 mg/kg bid x 7 d |
At 6-8 wks, tx rate: NVP 20.9% NVP/ZDV 15.3% (26.8% efficacy); when limited to infants uninfected at birth: NVP 12.% vs NVP/ZDV 7.7% (36.4% efficacy) (Taha, 2003) |
| MALAWI (Fogarty) •Randomized, open label •Breastfeeding •N=894 |
No ARV | NVP 200 mg x 1 | No ARV | Arm 1: NVP 2 mg/kg x 1 at 48-72 hr Arm 2: NVP 2 mg/kg x 1 at 48-72 hr plus ZDV 4 mg/kg bid x 7 d |
At 6-8 wks, tx rate: NVP 14.1% NVP/ZDV 16.3% (p=.36) When limited to infants uninfected at birth: NVP 6.5% vs NVP/ZDV 6.9% (p=.88) (Taha, 2004) |