CompletedNCT00357552Updated Mar 20, 2018Results posted

Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy

An interventional study of Emtricitabine/Tenofovir disoproxil fumarate and Lopinavir/Ritonavir in HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 123
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Most anti-HIV regimens include a non-nucleoside reverse transcriptase inhibitor (NNRTI); however, some individuals fail on these regimens. The purpose of this study is to evaluate the safety and effectiveness of the protease inhibitor (PI) lopinavir/ritonavir (LPV/r) in HIV infected individuals who are failing an anti-HIV regimen that includes an NNRTI.

Read the detailed description

Standard effective antiretroviral therapy for HIV infected individuals includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRTIs) with either a PI or an NNRTI. However, three-drug regimens may not be ideal in resource-limited settings, where viral load and resistance testing may not be readily available. The purpose of this study is to evaluate the safety and efficacy of the PI LPV/r alone in treatment-experienced, PI-naive HIV infected individuals who are experiencing virologic failure on three-drug regimens.

This study will last 104 weeks. All participants will receive LPV/r twice daily for up to 104 weeks. Participants who experience virologic failure will receive emtricitabine/tenofovir disoproxil fumarate once daily in addition to LPV/r twice daily for the remainder of the study.

There will be 16 study visits for participants on LPV/r monotherapy and 12 study visits for participants who have intensified LPV/r with emtricitabine/tenofovir disoproxil fumarate. Blood collection and clinical assessment will occur at all visits; urine collection and resistance testing will occur at selected visits.

Conditions studied

HIV Infections

Browse trials for

HIV Infections 4,258

Keywords

Treatment Experienced

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 123 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is the lead sponsor of 70 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria for Step 1 Participants:

HIV infected
Continuous treatment with a three-drug, NNRTI-containing regimen for at least 6 months prior to study entry
Viral load of 1,000 copies/ml or greater and less or equal to 200,000 copies/ml obtained within 30 days of study entry
Negative pregnancy test within 48 hours of study entry
Willing to use acceptable forms of contraception for the duration of the study
Laboratory values obtained within 30 days of study entry:
- Hemoglobin greater or equal to 8.0 g/dL
- Platelet count greater or equal to 50,000/mm3
- Estimated Creatinine Clearance greater or equal to 60 mL/min x ULN
- AST (SGOT), ALT (SGPT) and alkaline phosphatase \< 3 x ULN
- Total bilirubin less or equal to 2.5 x ULN
Ability and willingness of participant or legal guardian/representative to give informed consent

Inclusion Criteria for Step 2 Participants:

Virologic failure on LPV/r monotherapy defined as viral load of 400 copies/ml or greater after 24 consecutive weeks on LPV/r monotherapy OR virologic failure after initial viral suppression on LPV/r monotherapy
Estimated creatinine clearance of 60 ml/min or greater
Negative pregnancy test within 48 hours of entry into Step 2
Willing to use acceptable forms of contraception for the duration of the study

Exclusion Criteria for All Participants:

Breastfeeding
Known allergy or sensitivity to study drugs
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence to study requirements
History of chronic hepatitis B infection

Exclusion Criteria for Step I Participants:

Prior use of any protease inhibitor treatment
Acute therapy for any serious medical condition within 14 days of study entry. For ongoing or chronic therapy, the participant must be on the treatment regimen for at least 14 days, and clinically stable prior to entry. If a potential participant has TB and has received treatment for more than 2 weeks, the TB treatment would have to be modified to include a rifabutin-containing regimen. TB compatible syndromes will also be carefully evaluated prior to entry.

Exclusion Criteria for Step 2 Participants:

Active opportunistic infection, including tuberculosis (TB)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 123 participants (actual)

Study arms

Experimental
LPV/r monotherapy
Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.
Drug: Emtricitabine/Tenofovir disoproxil fumarate · Drug: Lopinavir/Ritonavir

Interventions

DrugEmtricitabine/Tenofovir disoproxil fumarate
Once daily
Also known as: Truvada
DrugLopinavir/Ritonavir
Twice daily
Also known as: Kaletra, Aluvia

What researchers measure

Primary outcomes

Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to \< 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA \>= 400 copies/mL after confirmed HIV-1 RNA \< 400 copies/mL.
Time frame: From study entry to week 24
Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.
Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time frame: From study entry to week 24

Secondary outcomes

Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.
Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.
Time frame: Screening
Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 \>= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA \>= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.
Time frame: Study entry to Week 104
Number of Participants With Study-targeted Diagnoses and Clinical Events
Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.
Time frame: Study entry to week 104
Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.
Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.
Time frame: At time of virologic failure
Percentage of Subjects Reporting Not Skipping Medications in the Last Month.
The percentage of subjects reporting never missing medications in the last month.
Time frame: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24
Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification
25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time frame: From LPV/r intensification to week 104
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma
Proportion of DBS samples with HIV-1 RNA level \<= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level \<= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both \<= 400 copies/mL or both \> 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature).
Time frame: At study entry and weeks 24 and 48
HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma
HIV-1 viral sequencing as ascertained from paired DBS and plasma
Time frame: At study entry and virologic failure
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104
Time frame: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104
Change in CD4+ Cell Counts From Study Entry to Week 104
Time frame: Study entry and week 104

Results

Posted Sep 25, 2012

Participant flow

Screening

Participant flow — Screening
Milestone	LPV/r Monotherapy
Started	207
Completed	123
Not completed	84
Withdrew: Did not meet eligibility criteria	84

Weeks 0 to 24

Participant flow — Weeks 0 to 24
Milestone	LPV/r Monotherapy
Started	123
Completed	122
Not completed	1
Withdrew: Death	1

Weeks 24 to 104

Participant flow — Weeks 24 to 104
Milestone	LPV/r Monotherapy
Started	122
Completed	117
Not completed	5
Withdrew: Death	3
Withdrew: Not able to get to clinic	2

Outcome measures

PrimaryPercentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy

Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to \< 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA \>= 400 copies/mL after confirmed HIV-1 RNA \< 400 copies/mL.

Time frame:: From study entry to week 24
Reported as:: Number · percentage of enrolled subjects

Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
percentage of enrolled subjects	LPV/r Monotherapy
Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy	87 (81 to 92)

Statistical analysis

LPV/r Monotherapy · confidence interval · Proportion: 87 · 90% CI 81 to 92exact confidence interval

PrimaryProbability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.

Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

Time frame:: From study entry to week 24
Reported as:: Number · cumulative probability of grade 3 or 4

Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.
cumulative probability of grade 3 or 4	LPV/r Monotherapy
Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.	0.23 (0.16 to 0.31)

SecondaryNumber of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.

Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.

Time frame:: Screening
Reported as:: Number · number of screened subjects

Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.
number of screened subjects	All Screened Subjects With Available Sequences
At least one NNRTI-associated mutation	201
At least one NRTI-associated mutation	197

SecondaryTime to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.

25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 \>= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA \>= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.

Time frame:: Study entry to Week 104
Reported as:: Number · weeks

Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
weeks	LPV/r Monotherapy
Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.	48.0 (40.0 to 80.0)

SecondaryNumber of Participants With Study-targeted Diagnoses and Clinical Events

Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.

Time frame:: Study entry to week 104
Reported as:: Number · participants

Number of Participants With Study-targeted Diagnoses and Clinical Events
participants	LPV/r Monotherapy
Number of Participants With Study-targeted Diagnoses and Clinical Events	39

SecondaryNumber of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.

Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.

Time frame:: At time of virologic failure
Reported as:: Number · participants

Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.
participants	Virologic Failures by Week 24.
Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.	2

SecondaryPercentage of Subjects Reporting Not Skipping Medications in the Last Month.

The percentage of subjects reporting never missing medications in the last month.

Time frame:: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24
Reported as:: Number · percentage of subjects with data

Percentage of Subjects Reporting Not Skipping Medications in the Last Month.
percentage of subjects with data	LPV/r Monotherapy
week 2 (N=120)	90
week 4 (N=121)	86.8
week 8 (N=123)	87.8
week 12 (N=123)	86.2
week 16 (N=122)	86.1
week 20 (N=120)	90.9
week 24 (N=122)	89.4

SecondaryTime to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification

25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

Time frame:: From LPV/r intensification to week 104
Reported as:: Number · weeks

Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification
weeks	LPV/r Monotherapy
Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification	26.0 (13.1 to 53.3)

SecondaryLevel of HIV-1 RNA as Ascertained From Paired DBS and Plasma

Proportion of DBS samples with HIV-1 RNA level \<= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level \<= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both \<= 400 copies/mL or both \> 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature).

Time frame:: At study entry and weeks 24 and 48
Reported as:: Number · proportion of samples

Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma
proportion of samples	LPV/r Monotherapy
study entry DBS <= 400 cp/mL	0.17
study entry plasma <= 400 cp/mL	0.00
study entry DBS & plasma concordance	0.83
week 24 DBS <= 400 cp/mL	0.82
week 24 plasma <= 400 cp/mL	0.80
week 24 DBS & plasma concordance	0.80
week 48 DBS <= 400 cp/mL	0.94
week 48 plasma <= 400 cp/mL	0.91
week 48 DBS & plasma concordance	0.97

SecondaryHIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma

HIV-1 viral sequencing as ascertained from paired DBS and plasma

Time frame:: At study entry and virologic failure

No measurements were reported for this outcome.

SecondaryProportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104

Time frame:: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104
Reported as:: Number · proportion of participants

Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104
proportion of participants	LPV/r Monotherapy
week 0 (N=123)	0.02
week 12 (N=122)	0.75
week 16 (N=121)	0.87
week 20 (N=115)	0.84
week 24 (N=122)	0.84
week 32 (N=121)	0.83
week 40 (N=118)	0.84
week 48 (N=118)	0.87
week 56 (N=120)	0.86
week 68 (N=116)	0.91
week 80 (N=117)	0.85
week 92 (N=116)	0.87
week 104 (N=117)	0.89

SecondaryChange in CD4+ Cell Counts From Study Entry to Week 104

Time frame:: Study entry and week 104
Reported as:: Median · cells/mm^3

Change in CD4+ Cell Counts From Study Entry to Week 104
cells/mm^3	LPV/r Monotherapy
Change in CD4+ Cell Counts From Study Entry to Week 104	213 (111 to 326)

Adverse events

Collected over From study entry up to 104 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
LPV/r	—	20/123 (16.3%)	122/123 (99.2%)

Most frequent serious events

Showing 10 of 18

Most frequent serious events
Event	LPV/r
HyperglycaemiaMetabolism and nutrition disorders	4/123
GastroenteritisInfections and infestations	2/123
Blood triglycerides increasedInvestigations	2/123
HyperlipidaemiaMetabolism and nutrition disorders	2/123
Acute myocardial infarctionCardiac disorders	1/123
DiarrhoeaGastrointestinal disorders	1/123
DeathGeneral disorders	1/123
Pneumonia bacterialInfections and infestations	1/123
Blood cholesterol increasedInvestigations	1/123
Blood phosphorus decreasedInvestigations	1/123

Most frequent other events

Showing 10 of 34

Most frequent other events
Event	LPV/r
Blood cholesterol increasedInvestigations	76/123
Blood sodium decreasedInvestigations	62/123
Low density lipoprotein increasedInvestigations	54/123
Blood phosphorus decreasedInvestigations	39/123
Neutrophil count decreasedInvestigations	38/123
CoughRespiratory, thoracic and mediastinal disorders	34/123
Blood glucose increasedInvestigations	31/123
PyrexiaGeneral disorders	27/123
Blood bicarbonate decreasedInvestigations	24/123
Upper respiratory tract infectionInfections and infestations	22/123

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	LPV/r Monotherapy
<=18 years	0
Between 18 and 65 years	123
>=65 years	0

Age, Continuous
Age, Continuous(years)	LPV/r Monotherapy
Mean	39.4 ± 8.2

Sex: Female, Male
Sex: Female, Male(Participants)	LPV/r Monotherapy
Female	70
Male	53

Region of Enrollment
Region of Enrollment(participants)	LPV/r Monotherapy
South Africa	22
Thailand	24
India	12
Malawi	40
Tanzania	25

Study locations

5 sites

Y.R.G Ctr, for AIDS Research and Education (11701)
Chennai, India
University of North Carolina Lilongwe CRS (12001)
Lilongwe, Malawi
Wits HIV CRS (11101)
Johannesburg, Gauteng, South Africa
Kilimanjaro Christian Medical CRS
Moshi, Tanzania
Chiang Mai University ACTG CRS (11501)
Chiang Mai, 50202, Thailand

References and documents

Publications

Arribas JR, Pulido F, Delgado R, Lorenzo A, Miralles P, Arranz A, Gonzalez-Garcia JJ, Cepeda C, Hervas R, Pano JR, Gaya F, Carcas A, Montes ML, Costa JR, Pena JM. Lopinavir/ritonavir as single-drug therapy for maintenance of HIV-1 viral suppression: 48-week results of a randomized, controlled, open-label, proof-of-concept pilot clinical trial (OK Study). J Acquir Immune Defic Syndr. 2005 Nov 1;40(3):280-7. doi: 10.1097/01.qai.0000180077.59159.f4. PubMed 16249701 ↗
Campo RE, Lalanne R, Tanner TJ, Jayaweera DT, Rodriguez AE, Fontaine L, Kolber MA. Lopinavir/ritonavir maintenance monotherapy after successful viral suppression with standard highly active antiretroviral therapy in HIV-1-infected patients. AIDS. 2005 Mar 4;19(4):447-9. doi: 10.1097/01.aids.0000161777.38438.ed. No abstract available. PubMed 15750401 ↗
Joly V, Descamps D, Peytavin G, Touati F, Mentre F, Duval X, Delarue S, Yeni P, Brun-Vezinet F. Evolution of human immunodeficiency virus type 1 (HIV-1) resistance mutations in nonnucleoside reverse transcriptase inhibitors (NNRTIs) in HIV-1-infected patients switched to antiretroviral therapy without NNRTIs. Antimicrob Agents Chemother. 2004 Jan;48(1):172-5. doi: 10.1128/AAC.48.1.172-175.2004. PubMed 14693536 ↗
Bartlett JA, Ribaudo HJ, Wallis CL, Aga E, Katzenstein DA, Stevens WS, Norton MR, Klingman KL, Hosseinipour MC, Crump JA, Supparatpinyo K, Badal-Faesen S, Kallungal BA, Kumarasamy N. Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings. AIDS. 2012 Jul 17;26(11):1345-54. doi: 10.1097/QAD.0b013e328353b066. PubMed 22441252 ↗
Kumarasamy N, Aga E, Ribaudo HJ, Wallis CL, Katzenstein DA, Stevens WS, Norton MR, Klingman KL, Hosseinipour MC, Crump JA, Supparatpinyo K, Badal-Faesen S, Bartlett JA. Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230. Clin Infect Dis. 2015 May 15;60(10):1552-8. doi: 10.1093/cid/civ109. Epub 2015 Feb 18. PubMed 25694653 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00357552
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party: Sponsor
First posted: Jul 27, 2006
Start date: Jan 2008
Primary completion: Oct 2010
Completion: May 2012
Results posted: Sep 25, 2012
Last update: Mar 20, 2018

Study contacts

Nagalingeswaran Kumarasamy, MBBS, PhD

study chair · Y. R. Gaitonde Centre for AIDS Research and Education

John Bartlett, MD

study chair · Division of Infectious Diseases, Duke University Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

HIV Infections→

Other studies from this sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Start the discussion