HIVPhase 4NCT01088516
Clinical Study of an Aluvia-based HAART Regimen for Prevention of Mother-to-child HIV Transmission in Africa
A Phase 4 study testing Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC in people with HIV, run by University of Zambia at 1 site in Zambia.
Trial summary
Therapeutic options to prevent vertical transmission of HIV remain limited. Combination antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is generally recommended in the developed world, both for its ability to reduce maternal viral load, and thus the likelihood of transmission, as… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteZambia
- Study dates
- Dec 2008to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Minimum age 15 years
- Pregnancy and ability to initiate therapy between 14-30 weeks gestation
- HIV seropositivity
- Intention to exclusively breastfeed for 6 months
- Ability to give informed consent
- Ability to attend follow-up visits
Who cannot join
- Previous HAART
- Pre-existing known major illnesses likely to influence pregnancy outcome or place participant at increased risk from adverse events from HAART therapy, including diabetes, severe renal, liver or heart disease, or active tuberculosis
- Severe anemia (Hemoglobin <8 gm/dL)
- Current and continuing therapy with selected medications which are either absolutely or relatively contraindicated for co-administration with Aluvia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of an Aluvia Based Highly Active Antiretroviral Therapy (HAART) Regimen in the Prevention of Mother to Child HIV Transmission (PMTCT) Antepartum, Intrapartum and Postpartum in Africa
Therapeutic options to prevent vertical transmission of HIV remain limited. Combination antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is generally recommended in the developed world, both for its ability to reduce maternal viral load, and thus the likelihood of transmission, as well as for its prevention of drug resistance mutations, which might otherwise reduce future options for therapy in the mother, infant, or both. Exclusive formula-feeding is also recommended in the developed world (where clean water sources \& adequate hygiene is reliably available) to prevent HIV transmission through breastmilk, however, this is not yet a feasible option in many developing world settings due to economic, infrastructure, social and infant-health reasons.
The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP; established capsule form is known as Kaletra) to improve maternal virological control and thus mother-to-child-transmission (MTCT).
Read more
Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir) can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and then subsequent complementary feeding to be carried out with minimum risk to the mother and infant.
- Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds
- Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant will be given as per current Zambian practice
- Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability to wean by 13 months, however, drug will be continued until the mother has achieved a complete wean.
- Follow-up period: Mother \& child will be followed to an infant age of 24 months, as per schedule-of-visits (approx every 3 months)
Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post weaning.
Read the detailed description
Study completed. Results are being published and the manuscript is in press as of June 2015
Ngoma MS, Misir A, Mutale W, Rampakakis E, Sampalis JS, Elong A, Chisele S, Mwale A, Mwansa JK, Mumba S, Chandwe M, Pilon R, Sandstrom P, Wu S, Yee K and Silverman MS. Efficacy of WHO recommendation for continued breastfeeding and maternal cART for prevention of perinatal and postnatal HIV transmission in Zambia. Journal of the International AIDS Society; 2015
- Conditions
- HIV
- Being tested
- Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC
- Keywords
- Human Immunodeficiency Virus, Vertical Transmission, Pregnancy, Breastfeeding, Prevention of mother to child transmission, HAART, Aluvia, Lopinavir, Africa, Infectious Disease Transmission, Vertical
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TCDrug
Also called Combivir (Zidovudine or AZT + 3TC), Aluvia (Lopinavir/Ritonavir)
Zidovudine 300mg PO BID + 3TC 150 mg PO BID + Lopinavir/Ritonavir (200/50 mg) two tablets PO BID
| Study group | Role | What they receive |
|---|---|---|
| Aluvia-based HAART | Experimental | Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds Receives: Drug: Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Negative Survival of Infants
Measured: to be assessed at: infant age 6 months, 3 months post-weaning from breastfeeding, infant/child age 24 months
Secondary outcomes (5)
Maternal survival, viral suppression and CD4 response
Measured: End-of-Study (Infant actual/predicted age 18-24 months)
Emergence of viral drug resistance in mothers or infants
Measured: End-of-Study (infant actual/predicted age 18-24 months)
Incidence of diarrhea, malnutrition/growth failure and pneumonia in infants
Measured: Infant actual/predicted age 1 year and 18-24 months
Cost-effectiveness analysis
Measured: End-of-Study (infant actual/predicted age 24 months)
Efficacy of therapy in prevention of transmission with supplemental feeding among those infants who remain PCR negative at 6 months of age
Measured: Infant age 6 months and 3-months post-wean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startDec 2008
- Primary completionNov 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Abbott
- Responsible party
- Principal investigator, Dr Michael Silverman, University of Zambia
- Investigators
- Michael Silverman, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088516
- Sponsor's protocol ID
- Aluvia Breastfeeding Study
- Other IDs
- A10-324
- Status last verified
- Jun 2015
- First submitted
- 25 Jan 2010
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Aluvia Based Highly Active Antiretroviral Therapy (HAART) Regimen in the Prevention of Mother to Child HIV Transmission (PMTCT) Antepartum, Intrapartum and Postpartum in Africa
- ClinicalTrials.gov ID
- NCT01088516
- Acronym / sponsor ID
- Aluvia Breastfeeding Study
- Conditions
- HIV
- Keywords
- Human Immunodeficiency Virus, Vertical Transmission, Pregnancy, Breastfeeding, Prevention of mother to child transmission, HAART, Aluvia, Lopinavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of ZambiaUniversity, hospital or other
- Collaborators
- University of Toronto, Abbott
- Study start
- Dec 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapeutic options to prevent vertical transmission of HIV remain limited. Combination antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is generally recommended in the developed world, both for its ability to reduce maternal viral load, and thus the likelihood of transmission, as well as for its prevention of drug resistance mutations, which might otherwise reduce future options for therapy in the mother, infant, or both. Exclusive formula-feeding is also recommended in the developed world (where clean water sources \& adequate hygiene is reliably available) to prevent HIV transmission through breastmilk, however, this is not yet a feasible option in many developing world settings due to economic, infrastructure, social and infant-health reasons.
The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP; established capsule form is known as Kaletra) to improve maternal virological control and thus mother-to-child-transmission (MTCT).
Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir) can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and then subsequent complementary feeding to be carried out with minimum risk to the mother and infant.
- Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds
- Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant will be given as per current Zambian practice
- Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability to wean by 13 months, however, drug will be continued until the mother has achieved a complete wean.
- Follow-up period: Mother \& child will be followed to an infant age of 24 months, as per schedule-of-visits (approx every 3 months)
Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post weaning.
Detailed description
Study completed. Results are being published and the manuscript is in press as of June 2015
Ngoma MS, Misir A, Mutale W, Rampakakis E, Sampalis JS, Elong A, Chisele S, Mwale A, Mwansa JK, Mumba S, Chandwe M, Pilon R, Sandstrom P, Wu S, Yee K and Silverman MS. Efficacy of WHO recommendation for continued breastfeeding and maternal cART for prevention of perinatal and postnatal HIV transmission in Zambia. Journal of the International AIDS Society; 2015
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aluvia-based HAART | Experimental | Drug: Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TCStudy regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age 15 years
- Pregnancy and ability to initiate therapy between 14-30 weeks gestation
- HIV seropositivity
- Intention to exclusively breastfeed for 6 months
- Ability to give informed consent
Key exclusion criteria (4 listed)
- Previous HAART
- Pre-existing known major illnesses likely to influence pregnancy outcome or place participant at increased risk from adverse events from HAART therapy, including diabetes, severe renal, liver or heart disease, or active tuberculosis
- Severe anemia (Hemoglobin <8 gm/dL)
- Current and continuing therapy with selected medications which are either absolutely or relatively contraindicated for co-administration with Aluvia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TCAlso: Combivir (Zidovudine or AZT + 3TC), Aluvia (Lopinavir/Ritonavir)Zidovudine 300mg PO BID + 3TC 150 mg PO BID + Lopinavir/Ritonavir (200/50 mg) two tablets PO BID | Drug | Aluvia-based HAART |
Primary outcome
HIV Negative Survival of Infants
Time frame: to be assessed at: infant age 6 months, 3 months post-weaning from breastfeeding, infant/child age 24 months
5 secondary outcomes
Maternal survival, viral suppression and CD4 response
Time frame: End-of-Study (Infant actual/predicted age 18-24 months)
Emergence of viral drug resistance in mothers or infants
Time frame: End-of-Study (infant actual/predicted age 18-24 months)
Incidence of diarrhea, malnutrition/growth failure and pneumonia in infants
Time frame: Infant actual/predicted age 1 year and 18-24 months
Cost-effectiveness analysis
Time frame: End-of-Study (infant actual/predicted age 24 months)
Efficacy of therapy in prevention of transmission with supplemental feeding among those infants who remain PCR negative at 6 months of age
Time frame: Infant age 6 months and 3-months post-wean
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Silverman, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC in people with HIV, run by University of Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Negative Survival of Infants (time frame: to be assessed at: infant age 6 months, 3 months post-weaning from breastfeeding, infant/child age 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.