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HIV InfectionsPhase 2P1060NCT00307151

Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

A Phase 2 study testing Lamivudine, Lopinavir/ritonavir and Nevirapine in people with HIV Infections, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 10 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV. Read more about this study

Who is it for?
Ages 2 to 36 months
Conditions the study is for
HIV Infections
What is being tested?
Lamivudine, Lopinavir/ritonavir and Nevirapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
10 sitesin 7 countries
Study dates
Dec 2005to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 2 to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • age >=6 months to < 36 months (decreased to 2 months in protocol version 4.0)>>
  • HIV infected>>
  • Viral load greater than 5,000 copies/ml within 60 days of study entry>>
  • Treatment naive except for antiretrovirals (ARV) used to prevent MTCT (infant ARV use for <=1 week postpartum for prevention of MTCT allowed) >>
  • Eligible for treatment according to WHO pediatric algorithm (updated in protocol version 1.0, Letter of amendment (LOA)#1) and protocol version 2.0, LOA#3). Subjects with active opportunistic infections were not eligible for study participation until they had been treated and were clinically stable >>
  • Parent or legal guardian willing to provide signed informed consent>>
Show all 22Show fewer
  • Documentation of maternal or infant NVP exposure or a highly reliable verbal report. (Updated in protocol version 2.0, LOA#3 to require written clinic/hospital documentation of infant exposure to SD NVP)>>
  • Use of maternal ARV, including NVP, permitted during pregnancy>>
  • One or more of the following: strict formula feeding, initial infant HIV diagnosis occurring while younger than 60 days of age, or an initial AIDS-defining illness diagnosis by WHO criteria while younger than 60 days of age. >>
  • Use of maternal ARVs, excluding NNRTIs, permitted during pregnancy>>
  • Evidence of lack of prior NVP exposure (added in protocol version 2.0, LOA#3) by review of maternal and child medical records or health card (or other written documentation) for evidence of NVP exposure to mother or infant during pregnancy, labor, and delivery. If no written documentation showing lack of NVP use was shown in these records or if these records were not available for review, then a verbal report considered to be highly reliable by the study nurse was acceptable AND one or more of the following: >>
  • Study subject born before single dose NVP was available for prevention of MTCT of HIV in the location of birth of study subject>>
  • Study subject born before the biological mother's first positive HIV test>>
  • Site staff had another reason to believe the subject had not been exposed to NVP >> >> Exclusion Criteria for All Participants:>>
  • Grade 2 or higher aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at study screening>>
  • Grade 3 or higher laboratory toxicity at study screening>>
  • Received ARVs for anything other than the prevention of intrapartum MTCT. Infants who received ARVs after the first week of life (e.g., for the prevention of MTCT of HIV through breastfeeding) were excluded >>
  • Acute serious infections requiring active treatment. Subjects could be receiving treatment for active TB if it did not include rifamycin drugs>>
  • Receiving chemotherapy for an active tumor>>
  • History of a cardiac conduction abnormality and underlying structural heart disease>>
  • Required certain medications>> >> Exclusion Criteria for Cohort I: >>
  • History of or currently breastfeeding. Breastfed infants with a positive HIV test or who had experienced an AIDS-defining illness by WHO criteria at 60 days of age or younger were not excluded>>

Who cannot join

  • Exposure to any maternal NVP or other NNRTI prior to or during the pregnancy or while breastfeeding>>
  • Exposure of infant to NVP at any time including during the first week of life

Trial locations and contacts

10 sites in 7 countries.

10 sites in 7 countries

South Africa4 sites

  • University of Stellenbosch-Tygerberg Hospital, South Africa

    Cape Town, 7700

  • Harriet Shezi Clinic at Chris Hani Baragwanath Hospital

    Johannesburg, 2013

  • Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

    Johannesburg

  • Nelson R. Mandela School of Medicine, University of Kwazulu

    Natal, Durban, 50202

Other trials in South Africa

India1 site

  • BJ Medical College CRS

    Pune, Maharashtra, 411001

Other trials in India

Malawi1 site

  • University of North Carolina Lilongwe CRS

    Mzimba Road, Lilongwe

Other trials in Malawi

Tanzania1 site

  • Kilimanjaro Christian Medical CRS

    IDC Research Offices, Moshi

Other trials in Tanzania

Uganda1 site

  • Makerere University

    Kampala

Other trials in Uganda

Zambia1 site

  • George Clinic CRS

    Lusaka

Other trials in Zambia

Zimbabwe1 site

  • UZ-College of Health Sciences

    Harare

Other trials in Zimbabwe

About this study

Official title: Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission

A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP for prevention of MTCT.

>>

>> A five year follow up has been added to the study.

Read the detailed description

Single dose nevirapine (SD NVP) has greatly reduced the rate of mother-to-child transmission (MTCT) of HIV. Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens are recommended for use by the World Health Organization (WHO) in resource-limited settings. However, research suggests that mothers and infants exposed to SD NVP experience higher virologic failure rates when treated with NNRTI-based regimens than their unexposed counterparts. Data show that the use of SD NVP is associated with NNRTI resistance in HIV infected women and infants. The purpose of this trial was to compare and evaluate virologic responses to an NNRTI-based regimen versus a protease-inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP intrapartum and after birth.

>>

>> Participants were enrolled into one of two Cohorts with proposed enrollment into each Cohort of 288 participants. Cohort I participants must have received SD NVP for prevention of MTCT. Cohort II participants and their mothers must not have previously received NVP or any other NNRTIs. Participants in both Cohorts were randomly assigned to receive either an NNRTI (Coh I:NVP and Coh II: NVP) or PI (Coh I: LPV/r and Coh II: LPV/r) -based regimen. The NNRTI-based regimen included NVP, zidovudine (ZDV) and lamivudine (3TC). The PI-based regimen included lopinavir/ritonavir (LPV/r), ZDV and 3TC. If participants experienced adverse reactions to ZDV, stavudine (d4T) could be substituted. Randomization was stratified by age (6-<12 months vs. >=12 months, with the 2-<6 month stratum added in protocol version 4.0 when the lower age limit was decreased from 6 months to 2 months).

>>

>> Study visits were scheduled at entry, weeks 2, 4, 8, 12, 16, 24 and then every 24 weeks. A physical exam, blood collection, and assessments of HIV-related symptoms occurred at all visits.

>>

>> Based on a Data Safety and Monitoring Committee (DSMB) review of study data on April 20 2009, enrollment to Cohort I was closed and interim results released. Data from this and another similar study (AIDS Clinical Trials Group (ACTG) A5208) conducted in mothers, showed that the PI-based regimen was more effective than the NNRTI-based regimen in infants who had received SD NVP for prevention of MTCT. Cohort II was allowed to remain open for enrollment and the lower age limit for enrollment reduced from 6 months to 2 months.

>>

>> In June 2010, follow-up for all subjects was extended from the original 24 weeks beyond enrollment of the last subject to 48 weeks. On October 27 2010, the DSMB conducted a final review of Cohort II data, and recommended results be unblinded and released. As found in Cohort I, the PI-based regimen was more effective than the NNRTI-based regimen in infants who had not been previously exposed to SD NVP for PMTCT. Primary and secondary outcome results for Cohort I include all follow-up until April 20, 2009 and for Cohort II, all follow-up until October 27, 2010.

>>

>> Version 5.0 of the protocol (March 21, 2011) extended follow-up on all subjects for an additional 5 years to December 2016. The purpose of the extension was to collect long term safety and virologic efficacy data in this study population and to pilot administration of a series of neuropsychological tests. During the extension, participants did not receive any medications through the study, but instead through their local clinics. Clinic visits took place every 3 months. Adverse event summaries use all follow-up in both Cohorts until December, 2016.

>>

>>

Conditions
HIV Infections
Being tested
Lamivudine, Lopinavir/ritonavir, Nevirapine, Zidovudine
Keywords
Treatment Naive, Mother-To-Child Transmission, MTCT, Pediatrics, Viral resistance
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LamivudineDrug

    Also called 3TC, Epivir

    4 mg/kg twice daily

  • Lopinavir/ritonavirDrug

    Also called LPV/r, Kaletra, LPV/RTV

    16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg

  • NevirapineDrug

    Also called NVP, Viramune

    Initially: 4 mg/kg for 14 days, then 7 mg/kg twice daily. In protocol version 2.0, Letter of Amendment 1 (September 2007), NVP dose increased to conform with WHO guidelines to: 160 to 200 mg/m^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m^2/dose to max 200 mg twice daily

  • ZidovudineDrug

    Also called ZDV, AZT, Retrovir

    180 mg/m^2 twice daily

Study groups in NCT00307151
Study groupRoleWhat they receive
Coh I: NVPExperimentalCohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
Receives: Drug: Lamivudine; Drug: Nevirapine; Drug: Zidovudine
Coh I: LPV/rExperimentalCohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
Receives: Drug: Lamivudine; Drug: Lopinavir/ritonavir; Drug: Zidovudine
Coh II: NVPExperimentalCohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
Receives: Drug: Lamivudine; Drug: Nevirapine; Drug: Zidovudine
Coh II: LPV/rExperimentalCohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
Receives: Drug: Lamivudine; Drug: Lopinavir/ritonavir; Drug: Zidovudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment

    Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.

    Measured: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

Secondary outcomes (8)

  1. Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment

    Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.

    Measured: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

  2. Percent of Participants Experiencing Virologic Failure

    Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.

    Measured: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

  3. Time From Randomization to Virologic Failure

    Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death.

    Measured: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

  4. Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment

    Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.

    Measured: On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

  5. Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus

    Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint

    Measured: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

  6. Change in CD4 Percent From Entry to Week 48

    Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.

    Measured: 48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

  7. Time From Randomization to HIV-related Disease Progression or Death

    HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.

    Measured: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

  8. Time From Randomization to Death

    Results report 2nd percentile of time from randomization to death

    Measured: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionDec 2010
  4. Study completionDec 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307151
Sponsor's protocol ID
IMPAACT P1060
Other IDs
U01AI068632
Acronym
P1060
Status last verified
Mar 2017
First submitted
24 Mar 2006
Last updated
13 Apr 2017
Data monitoring committee
Yes

Publications

  • Arrive E, Newell ML, Ekouevi DK, Chaix ML, Thiebaut R, Masquelier B, Leroy V, Perre PV, Rouzioux C, Dabis F; Ghent Group on HIV in Women and Children. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int J Epidemiol. 2007 Oct;36(5):1009-21. doi: 10.1093/ije/dym104. Epub 2007 May 28.

    PubMed 17533166

  • Chi BH, Sinkala M, Stringer EM, Cantrell RA, Mtonga V, Bulterys M, Zulu I, Kankasa C, Wilfert C, Weidle PJ, Vermund SH, Stringer JS. Early clinical and immune response to NNRTI-based antiretroviral therapy among women with prior exposure to single-dose nevirapine. AIDS. 2007 May 11;21(8):957-64. doi: 10.1097/QAD.0b013e32810996b2.

    PubMed 17457089

  • Eshleman SH, Hoover DR, Hudelson SE, Chen S, Fiscus SA, Piwowar-Manning E, Jackson JB, Kumwenda NI, Taha TE. Development of nevirapine resistance in infants is reduced by use of infant-only single-dose nevirapine plus zidovudine postexposure prophylaxis for the prevention of mother-to-child transmission of HIV-1. J Infect Dis. 2006 Feb 15;193(4):479-81. doi: 10.1086/499967. Epub 2006 Jan 11.

    PubMed 16425125

  • White PD. What causes prolonged fatigue after infectious mononucleosis: and does it tell us anything about chronic fatigue syndrome? J Infect Dis. 2007 Jul 1;196(1):4-5. doi: 10.1086/518615. Epub 2007 May 24. No abstract available.

    PubMed 17538875

  • Sankatsing RR, Wit FW, Pakker N, Vyankandondera J, Mmiro F, Okong P, Kastelein JJ, Lange JM, Stroes ES, Reiss P. Effects of nevirapine, compared with lamivudine, on lipids and lipoproteins in HIV-1-uninfected newborns: the stopping infection from mother-to-child via breast-feeding in Africa lipid substudy. J Infect Dis. 2007 Jul 1;196(1):15-22. doi: 10.1086/518248. Epub 2007 May 16.

    PubMed 17538878

  • Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1510-20. doi: 10.1056/NEJMoa1000931.

    PubMed 20942667

  • Palumbo P, Violari A, Lindsey J, Hughes M, Jean-Philippe P, Mofenson L, Purdue L, Eshleman S for the IMPAACT P1060 Study Team. Nevirapine vs Lopinavir-ritonavir-based antiretroviral therapy in single dose Nevirapine-exposed HIV-infected infants: preliminary results from the IMPAACT P1060 Trial. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Capetown, July, 2009.

  • Palumbo P, Violari A, Lindsey J, Hughes M, Jean-Philippe P, Mofenson L, Bwakura-Dangarembizi M, Kamthunzi P, Eshleman S and Prudue L for the IMPAACT P1060 Team. Nevirapine (NVP)-vs. Lopinavir-Ritonavir (LPV/r)-based antiretroviral therapy (ART) among HIV-infected infants in resource-limited settings: The IMPAACT P1060 Trial. 18th Conference on Retroviruses and Opportunistic Infections, Boston, February, 2011.

  • Patel K, Lindsey J, Angelidou K, Aldrovandi G, Palumbo P; IMPAACT P1060 Study Team. Metabolic effects of initiating lopinavir/ritonavir-based regimens among young children. AIDS. 2018 Oct 23;32(16):2327-2336. doi: 10.1097/QAD.0000000000001980.

    PubMed 30102656

  • Angelidou K, Palumbo P, Lindsey J, Violary A, Archary M, Barlow L, Claggett B, Hughes M, Wei LJ; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1060 Study Team. Defining Study Outcomes That Better Reflect Individual Response to Treatment. Pediatr Infect Dis J. 2018 Mar;37(3):258-262. doi: 10.1097/INF.0000000000001766.

    PubMed 29189677

  • Barlow-Mosha L, Angelidou K, Lindsey J, Archary M, Cotton M, Dittmer S, Fairlie L, Kabugho E, Kamthunzi P, Kinikar A, Mbengeranwa T, Msuya L, Sambo P, Patel K, Barr E, Jean-Phillipe P, Violari A, Mofenson L, Palumbo P, Chi BH. Nevirapine- Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy in HIV-Infected Infants and Young Children: Long-term Follow-up of the IMPAACT P1060 Randomized Trial. Clin Infect Dis. 2016 Oct 15;63(8):1113-1121. doi: 10.1093/cid/ciw488. Epub 2016 Jul 20.

    PubMed 27439527

  • Lindsey JC, Hughes MD, Violari A, Eshleman SH, Abrams EJ, Bwakura-Dangarembizi M, Barlow-Mosha L, Kamthunzi P, Sambo PM, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Zimmer B, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P; P1060 Study Team. Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission. Pediatr Infect Dis J. 2014 Aug;33(8):846-54. doi: 10.1097/INF.0000000000000337.

    PubMed 25222305

  • Violari A, Lindsey JC, Hughes MD, Mujuru HA, Barlow-Mosha L, Kamthunzi P, Chi BH, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. N Engl J Med. 2012 Jun 21;366(25):2380-9. doi: 10.1056/NEJMoa1113249.

    PubMed 22716976

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lamivudine, Lopinavir/ritonavir and Nevirapine in people with HIV Infections, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 10 sites in 7 countries.

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 22 inclusion and 2 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Africa, India, Malawi, Tanzania, Uganda and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment (time frame: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00307151, which also lists 13 linked publications.

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 13 Apr 2017.

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