Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission (PMTCT)
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ClinicalTrials.gov Identifier: NCT00346567 |
Recruitment Status
:
Completed
First Posted
: June 30, 2006
Last Update Posted
: February 23, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Zidovudine and Lamivudine (Combivir) Drug: Emtricitabine and Tenofovir (Truvada) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 566 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT) |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily
|
Drug: Zidovudine and Lamivudine (Combivir) |
Experimental: 2
AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
|
Drug: Emtricitabine and Tenofovir (Truvada) |
- frequency of mother-to-child HIV transmission [ Time Frame: 6 weeks post partum ]
- frequency of NNRTI resistance development [ Time Frame: 6 weeks post partum ]
- Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia [ Time Frame: Delivery, day 7, day 42 and month 9 post partum ]
- Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D [ Time Frame: Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.
Exclusion Criteria:
- CD4 less than 350 x10(6)/L, suffering from systemic diseases in need of medical treatment e.g. TB, renal or liver failure etc.
- Creatinin higher than 1,5 mg/dL, Alanine aminotransferase above 140 U/L

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346567
Tanzania | |
Bombo Regional Hospital | |
Tanga, Tanzania |
Study Director: | Terese L Katzenstein, MD Ph.D. | Rigshospitalet, Denmark |
Responsible Party: | Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet |
ClinicalTrials.gov Identifier: | NCT00346567 History of Changes |
Other Study ID Numbers: |
comtru |
First Posted: | June 30, 2006 Key Record Dates |
Last Update Posted: | February 23, 2016 |
Last Verified: | February 2009 |
Keywords provided by Rigshospitalet, Denmark:
mother-to-child-transmission PMTCT HIV resistance NNRTI |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Lamivudine Emtricitabine Zidovudine Nevirapine |
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine, zidovudine drug combination Reverse Transcriptase Inhibitors Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |