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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT services, to better understand the incremental benefits (e.g. reduction in HIV transmission, improvements in HIV-free survival) and risks (e.g. drug toxicities) of the routine HAART strategy, in comparison to HIV-infected pregnant women accessing the Zambian Standard of Care services.
The investigators will test the hypothesis that routine use of HAART produces significant reductions in HIV transmission rates, with only minimal side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine three-drug antiretroviral prophyalxis | Experimental | Cohort of 160 HIV-infected women, approached at > 28 weeks gestation and initiated on routine HAART for the purposes of PMTCT. |
|
| Control arm | No Intervention | A cohort of 160 women will be enrolled from the control clinics, from 28 weeks gestation onward. At these sites, the antenatal zidovudine will be offered, with provision of single-dose nevirapine for self-administration in labor. This practice is in accordance with the current standard of care recommended by the Zambian National Guidelines for PMTCT. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine three-drug antiretroviral prophylaxis | Drug | Women who are identified as HIV-infected will be offered routine combination antiretroviral prophylaxis starting at 28 weeks gestation (timing consistent with Zambian national guidelines for short-course ZDV). The first-line combination provided to pregnant women will be standardized following consultation with the Ministry of Health, but will likely include ZDV, lamivudine (3TC) and either NVP or lopinavir / ritonavir. In women who with moderate to severe anemia, ZDV is substituted with stavudine (d4T). In accordance with the Zambian national guidelines, any patients who are started on NVP will begin with a once daily dose for two weeks before increasing to the regular twice daily schedule |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Infection | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Infection | 6 weeks, 6 months and 24 months | |
| Infant survival | 12 and 24 months | |
| HIV-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Chi, M.D | Centre for Infectious Disease Research in Zambia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDRZ | Lusaka | Lusaka Province | 34681 | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23324656 | Result | Gartland MG, Chintu NT, Li MS, Lembalemba MK, Mulenga SN, Bweupe M, Musonda P, Stringer EM, Stringer JS, Chi BH. Field effectiveness of combination antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission in rural Zambia. AIDS. 2013 May 15;27(8):1253-62. doi: 10.1097/QAD.0b013e32835e3937. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| 12 months and 24 months |
| Incidence of maternal toxicity to HAART regimens | 24 months |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |