Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Abacavir; Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Ritonavir; Zidovudine

Criteria

Note: The pharmacokinetics testing portion of this study has been discontinued in Version 2.0 of this protocol.

Inclusion Criteria for Mothers:

• HIV infected

• Between the 12th and 30th week of pregnancy

• Intend to continue pregnancy

• Viral load less than 55,000 copies/ml within 30 days of study entry

• CD4 count greater than 350 cells/ml within 30 days of study entry

• Have not previously taken anti-HIV medications (women who have taken 8 weeks or fewer of zidovudine are still eligible) OR have taken anti-HIV medication but have been off treatment for more than 180 days

• Intend to stop taking anti-HIV medications after pregnancy

• Willing to have her infant tested for HIV

• Parent or guardian willing to provide informed consent, if applicable

• Have access to a participating site and are willing to be followed for the duration of the study

Exclusion Criteria for Mothers:

• Chemotherapy for active cancer

• Active opportunistic infection or severe medical condition within 14 days of study entry

• Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry

• Certain abnormal laboratory values

• Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded.

• Current alcohol or other substance abuse that, in the opinion of the investigator, may interfere with the study

• Acute hepatitis within 90 days of study entry

• Major birth defects in infant

• Severe skin disorder (e.g., eczema or psoriasis) requiring systemic treatment

• Require certain medications

• Medical condition that may, in the opinion of the investigator, interfere with the study

• Intend to breastfeed