A Phase 2 interventional study of Emtricitabine/Tenofovir Disoproxil Fumarate and Lamivudine/Zidovudine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 8 sites in 6 countries. Open to female participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance in the mother, potentially ruling out some treatment options in the future. The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.
The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.
A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to other nonnucleoside reverse transcriptase inhibitors (NNRTI) in the mother; as a result, future treatment options may be limited for these HIV infected women. The purpose of the study is to determine which of three ART regimens most effectively deters the development of maternal NVP resistance in HIV infected pregnant women postpartum. This study also compared the effectiveness of short-term versus long-term ART in discouraging the development of maternal NVP resistance.
Some mothers in this study received ZDV monotherapy prior to SD NVP administration; initiation of ZDV monotherapy was at the discretion of the site investigator and was be provided by this study. Randomization was stratified by receipt of ZDV monotherapy during the pregnancy.
Prior to labor, mothers were randomly assigned to receive SD NVP at the onset of labor and one of three postpartum ART regimens: 3TC/ZDV, FTC/TDF, and LPV/r. In addition, participants were randomly assigned to receive 7 or 21 days of their assigned postpartum treatment.
Mothers were followed for 96 weeks following delivery; there were 11 study visits for mothers during the study. At the onset of labor, medical and medication history, a targeted physical exam, and an obstetrical exam occurred. Additional physical exams occurred on Day 1 and Weeks 1 and 3. Blood collection occurred at 8 study visits between Weeks 3 and 96. Infants were followed for up to 96 weeks after birth; there were 8 study visits for infants during the study. Infants who had ever been breastfed had study visits at Weeks 16, 24, 48, and 96, and at about 1 and 2 years of age. A physical exam, medication history, and blood collection occurred at each infant visit. Mothers and infants could be prescribed continuing ART, but such ART was be provided by this study.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 484 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria for Mothers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
Drug: Lamivudine/Zidovudine · Drug: single dose Nevirapine
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
Drug: Lamivudine/Zidovudine · Drug: single dose Nevirapine
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate · Drug: single dose Nevirapine
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate · Drug: single dose Nevirapine
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
Drug: Lopinavir/Ritonavir · Drug: single dose Nevirapine
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
Drug: Lopinavir/Ritonavir · Drug: single dose Nevirapine
200mg/300mg as one tablet taken orally once daily
Also known as: FTC/TDF
Drug pages: Lamivudine · Zidovudine
150mg/300mg as one tablet taken orally twice daily
Also known as: 3TC/ZDV
133.3mg/33.3mg as three capsules taken orally twice daily
Also known as: LPV/r
one 200 mg tablet taken orally
Also known as: SD NVP
Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint. 10 participants who did not have resistance samples available were excluded from the primary endpoint analysis.
Time frame: 2 and 6 weeks after completion of treatment
Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.
Time frame: 2 and 6 weeks after completion of treatment
Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.
Time frame: 2 and 6 weeks after completion of treatment
Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12
Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12. Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death
Time frame: From first day of study treatment to week 12
Number of Participants Who Discontinued Study Treatment Prematurely
participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.
Time frame: From first day of study treatment to last day of study treatment (up to 21 days)
Study participants were recruited at 8 sites: 2 from South Africa, 2 from India, and 1 each from Haiti, Uganda, Tanzania, and Malawi, between January 2007 to October 2009.
| Milestone | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) |
|---|---|---|---|---|---|---|
| Started | 73 | 68 | 75 | 67 | 71 | 68 |
| Completed | 72 | 67 | 72 | 66 | 70 | 66 |
| Not completed | 1 | 1 | 3 | 1 | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 3 | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 1 |
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint. 10 participants who did not have resistance samples available were excluded from the primary endpoint analysis.
| participants | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) |
|---|---|---|---|---|---|---|
| Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping | 1 | 0 | 0 | 0 | 3 | 1 |
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.
| participants | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) |
|---|---|---|---|---|---|---|
| Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. | 0 | 1 | 1 | 1 | 1 | 0 |
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.
| participants | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) |
|---|---|---|---|---|---|---|
| Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. | 0 | 0 | 0 | 0 | 0 | 0 |
Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12. Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death
| participants | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) |
|---|---|---|---|---|---|---|
| Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12 | 5 | 1 | 1 | 0 | 2 | 2 |
participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.
| participants | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) |
|---|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Treatment Prematurely | 0 | 2 | 0 | 0 | 0 | 5 |
Collected over From first treatment date to 12 weeks of follow up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 7-day 3TC/ZDV | — | 2/73 (2.7%) | 0/73 (0%) |
| 21-day 3TC/ZDV | — | 0/68 (0%) | 0/68 (0%) |
| 7-day FTC/TDF | — | 1/75 (1.3%) | 0/75 (0%) |
| 21-day FTC/TDF | — | 0/67 (0%) | 0/67 (0%) |
| 7-day LPV/r | — | 1/71 (1.4%) | 0/71 (0%) |
| 21-day LPV/r | — | 0/68 (0%) | 0/68 (0%) |
| Event | 7-day 3TC/ZDV | 21-day 3TC/ZDV | 7-day FTC/TDF | 21-day FTC/TDF | 7-day LPV/r | 21-day LPV/r |
|---|---|---|---|---|---|---|
| Intra-uterine deathPregnancy, puerperium and perinatal conditions | 0/73 | 0/68 | 1/75 | 0/67 | 1/71 | 0/68 |
| AnaemiaBlood and lymphatic system disorders | 1/73 | 0/68 | 0/75 | 0/67 | 0/71 | 0/68 |
| Uterine ruptureInjury, poisoning and procedural complications | 1/73 | 0/68 | 0/75 | 0/67 | 0/71 | 0/68 |
| StillbirthPregnancy, puerperium and perinatal conditions | 1/73 | 0/68 | 0/75 | 0/67 | 0/71 | 0/68 |
| Age, Continuous(years) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 27 ± 6 | 27 ± 5 | 26 ± 5 | 26 ± 5 | 27 ± 6 | 26 ± 5 | 27 ± 5 |
| Age, Customized(participants) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| Between 13 and 19 years | 2 | 1 | 5 | 3 | 3 | 3 | 17 |
| Between 20 and 29 years | 49 | 46 | 53 | 46 | 47 | 48 | 289 |
| Between 30 and 39 years | 20 | 20 | 16 | 18 | 19 | 16 | 109 |
| >= 40 years | 2 | 1 | 1 | 0 | 2 | 1 | 7 |
| Sex: Female, Male(Participants) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| Female | 73 | 68 | 75 | 67 | 71 | 68 | 422 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| Haiti | 12 | 11 | 10 | 7 | 9 | 9 | 58 |
| Tanzania | 3 | 1 | 3 | 3 | 2 | 2 | 14 |
| Uganda | 17 | 16 | 18 | 17 | 17 | 16 | 101 |
| South Africa | 13 | 8 | 10 | 9 | 10 | 10 | 60 |
| Malawi | 13 | 14 | 14 | 12 | 17 | 15 | 85 |
| India | 15 | 18 | 20 | 19 | 16 | 16 | 104 |
| Gestational age at NVP dosing, Continuous(weeks) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 38 ± 2 | 39 ± 2 | 38 ± 2 | 38 ± 3 | 38 ± 2 | 38 ± 2 | 38 ± 2 |
| Screening CD4 count Categorical(participants) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| 250-349 cells/mm^3 | 15 | 7 | 8 | 6 | 20 | 13 | 69 |
| 350-499 cells/mm^3 | 24 | 21 | 29 | 29 | 25 | 22 | 150 |
| >=500 cells/mm^3 | 34 | 40 | 38 | 32 | 26 | 33 | 203 |
| Screening CD4 count Continuous(cells/mm^3) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 538 ± 244 | 585 ± 215 | 537 ± 186 | 545 ± 191 | 505 ± 205 | 566 ± 249 | 545 ± 216 |
| Screening HIV-1 RNA Categorical(participants) | 7-day Lamivudine/Zidovudine (3TC/ZDV) | 21-day Lamivudine/Zidovudine (3TC/ZDV) | 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 7-day Lopinavir/Ritonavir (LPV/r) | 21-day Lopinavir/Ritonavir (LPV/r) | Total |
|---|---|---|---|---|---|---|---|
| <=400 copies/mL | 17 | 13 | 13 | 12 | 12 | 16 | 83 |
| 401-999 copies/mL | 12 | 8 | 7 | 11 | 6 | 4 | 48 |
| 1000-9999 copies/mL | 17 | 26 | 33 | 25 | 29 | 18 | 148 |
| 10000-99999 copies/mL | 17 | 17 | 18 | 14 | 20 | 26 | 112 |
| 100000-749999 copies/mL | 8 | 3 | 4 | 5 | 4 | 4 | 28 |
| >=750000 copies/mL | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Missing/Unknown | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
2 further baseline measures are reported on the registry.
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Studies of the drugs tested here: Lamivudine · Zidovudine
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