Who is sponsoring NCT00086359?

NCT00086359 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT00086359 study?

NCT00086359 studies HIV Infections.

What drugs are being tested in NCT00086359?

Interventions: Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine, Lopinavir/ritonavir.

What is the status of NCT00086359?

NCT00086359 is currently COMPLETED.

Last reviewed 2021-10-28 · How we verify

A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV

NCT00086359 Phase 3 COMPLETED

Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	COMPLETED
Enrolment	19
Start date	2004-07
Completion	2007-09

Conditions

HIV Infections

Interventions

Abacavir sulfate, lamivudine, and zidovudine
Lamivudine/zidovudine
Lopinavir/ritonavir

Primary outcomes

Proportion of women in each treatment group with virologic suppression to less than 400 copies/ml at 34th week of pregnancy (or last viral load prior to delivery, if delivery occurs before 34th week of pregnancy) while continuing on assigned therapy — at Week 34 of pregnancy

Countries

United States, Puerto Rico