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

NCT00086359 | Completed Phase 3

• 3 other identifiers: P103910046PACTG P1039
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 8

Brief 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).

Conditions

HIV Infections

Keywords

Treatment Naive; Perinatal Transmission; Mother-to-Child Transmission; MTCT; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Primary outcome, evaluating ART naive and ART experienced women

  throughout study

• HIV-related health status of women at delivery, determined by CD4 counts and plasma HIV-1 viral load in the two treatment groups and in ART naive and ART experienced women

  throughout study

• study treatment adherence and health status by self report

  throughout study

• HIV-related health status of women postpartum, determined by CD4 counts and plasma HIV-1 viral load

  at Months 3, 6 and 12 postpartum and prior to ART treatment

• development of HIV-1 genotypic resistance among women in each treatment group

  at delivery, Months 3, 6, and 12 postpartum, and in all cases of treatment failure

Study Arms (2)

A

EXPERIMENTAL

One pill of abacavir/lamivudine/zidovudine twice daily

Drug: Abacavir sulfate, lamivudine, and zidovudine

B

EXPERIMENTAL

One pill of zidovudine/lamivudine and four pills of lopinavir/ritonavir twice daily.

Drug: Lamivudine/zidovudine; Drug: Lopinavir/ritonavir

Interventions

Abacavir sulfate, lamivudine, and zidovudine DRUG

one pill twice daily

A

Lamivudine/zidovudine DRUG

one pill twice daily

B

Lopinavir/ritonavir DRUG

four pills twice daily

B

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (8)

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCSD Mother-Child-Adolescent Program CRS

San Diego, California, 92103, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33136, United States

Location

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

Chicago, Illinois, 60608, United States

Location

Bronx-Lebanon CRS

The Bronx, New York, 10457, United States

Location

Regional Med. Ctr. at Memphis

Memphis, Tennessee, 38105-2794, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico

Location

Related Publications (5)

• Cooper ER, Charurat M, Mofenson L, Hanson IC, Pitt J, Diaz C, Hayani K, Handelsman E, Smeriglio V, Hoff R, Blattner W; Women and Infants' Transmission Study Group. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):484-94. doi: 10.1097/00126334-200204150-00009.

  PMID: 11981365 BACKGROUND

• Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.

  PMID: 15332429 BACKGROUND

• Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.

  PMID: 14562860 BACKGROUND

• Thorne C, Newell ML. Mother-to-child transmission of HIV infection and its prevention. Curr HIV Res. 2003 Oct;1(4):447-62. doi: 10.2174/1570162033485140.

  PMID: 15049430 BACKGROUND

• Tuomala RE, Shapiro DE, Mofenson LM, Bryson Y, Culnane M, Hughes MD, O'Sullivan MJ, Scott G, Stek AM, Wara D, Bulterys M. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med. 2002 Jun 13;346(24):1863-70. doi: 10.1056/NEJMoa991159.

  PMID: 12063370 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir; Lamivudine; Zidovudine; lamivudine, zidovudine drug combination; Lopinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine; Pyrimidinones

Study Officials

• Andrew D. Hull, MD

  Department of Reproductive Medicine, Division of Perinatal Medicine, University of California, San Diego School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2004
• First Posted: July 1, 2004
• Study Start: July 1, 2004
• Study Completion: September 1, 2007
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

PR (1); US (7)