Trial · NCT00098293
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
NCT00098293, Phase 3, Completed, ViiV Healthcare; results first posted 2012-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine. Trials, record NCT00098293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
- NCT number
- NCT00098293
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 916 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- HIV-1
- Interventions
- Maraviroc + Zidovudine/Lamivudine, Efavirenz + Zidovudine/Lamivudine, Maraviroc (UK-427,857) + Zidovudine/Lamivudine
- First posted
- 2004-12-07
- Last updated
- 2013-10-09
- Results first posted
- 2012-10-05
- Limitations and caveats
Following DSMB decision to discontinue maraviroc 300 mg once daily, inferential statistical analyses was performed between maraviroc 300 mg twice daily and efavirenz 600 mg once daily only. Data at Week 24 was not analyzed as planned in protocol.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Week 48 | |
| Primary | Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Week 48 | Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. |
| Secondary | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression | Week 48 | |
| Secondary | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression | Week 96 | |
| Secondary | Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96 | Baseline, Week 48, Week 96 | Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. |
| Secondary | Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels | Baseline up to Week 48 and Week 96 | TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. |
| Secondary | Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96 | Baseline, Week 48, Week 96 | Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. |
| Secondary | Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96 | Baseline, Week 48, Week 96 | Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. |
| Secondary | Time to Virologic Failure | Week 48, Week 96 | Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up \[LTFU\];new anti-retroviral drug added \[except background drug change to drug of same class\];or on open label for early non-response or rebound). Failure:at Time 0 if level not \<400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level \<400 copies/mL(2 consecutive visits);failure if level \>=400 copies/mL(2 consecutive visits) or 1 visit \>=400 copies/mL followed by permanent discontinuation of drug or LTFU. |
| Secondary | Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48 | Baseline, time of failure through Week 48 | Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} \[R5\], C-X-C chemokine receptor type 4 {CXCR4} \[X4\], Dual/mixed \[DM\], or Non-reportable/Non-phenotypable \[NR/NP\]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load \<500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Week 48 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Week 48 | Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were \>80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression | Week 48 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression | Week 96 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F). | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96 | Baseline, Week 48, Week 96 | FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm. | log10 copies/mL | MEAN |
| SECONDARY | Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels | Baseline up to Week 48 and Week 96 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued. | log10 copies/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96 | Baseline, Week 48, Week 96 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF. | cells per microliter (cells/µL) | MEAN |
| SECONDARY | Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96 | Baseline, Week 48, Week 96 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF. | cells/µL | MEAN |
| SECONDARY | Time to Virologic Failure | Week 48, Week 96 | FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. | days | MEDIAN |
| SECONDARY | Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48 | Baseline, time of failure through Week 48 | FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline. | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group214
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | Less than 400 copies/mL | 61.5 | Percentage of participants | |
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Maraviroc Twice Daily + CBV (DB) | Less than 400 copies/mL | 70.6 | Percentage of participants | |
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Efavirenz Once Daily + CBV (DB) | Less than 400 copies/mL | 73.1 | Percentage of participants | |
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | Less than 50 copies/mL | 55.8 | Percentage of participants | |
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Maraviroc Twice Daily + CBV (DB) | Less than 50 copies/mL | 65.3 | Percentage of participants | |
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population | Efavirenz Once Daily + CBV (DB) | Less than 50 copies/mL | 69.3 | Percentage of participants | |
| Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Maraviroc Twice Daily + CBV (DB) | Less than 400 copies/mL | 75.00 | Percentage of participants | |
| Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Efavirenz Once Daily + CBV (DB) | Less than 400 copies/mL | 78.27 | Percentage of participants | |
| Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Maraviroc Twice Daily + CBV (DB) | Less than 50 copies/mL | 70.00 | Percentage of participants | |
| Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population | Efavirenz Once Daily + CBV (DB) | Less than 50 copies/mL | 74.44 | Percentage of participants |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 results by groupParticipant flow65
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind (DB) Phase | STARTED | Maraviroc Once Daily + CBV (DB) | 177 | |
| Double-blind (DB) Phase | STARTED | Maraviroc Twice Daily + CBV (DB and OL) | 368 | |
| Double-blind (DB) Phase | STARTED | Efavirenz Once Daily + CBV (DB and OL) | 372 | |
| Double-blind (DB) Phase | STARTED | Maraviroc Twice Daily + CBV (OL) | 0 | |
| Double-blind (DB) Phase | STARTED | Maraviroc Twice Daily + CBV (SP) | 0 | |
| Double-blind (DB) Phase | Treated | Maraviroc Once Daily + CBV (DB) | 174 | |
| Double-blind (DB) Phase | Treated | Maraviroc Twice Daily + CBV (DB and OL) | 360 | |
| Double-blind (DB) Phase | Treated | Efavirenz Once Daily + CBV (DB and OL) | 361 | |
| Double-blind (DB) Phase | Treated | Maraviroc Twice Daily + CBV (OL) | 0 | |
| Double-blind (DB) Phase | Treated | Maraviroc Twice Daily + CBV (SP) | 0 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 participant flowAdverse events1,060
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | 12 | 174 | |
| other | Anaemia | Blood and lymphatic system disorders | Maraviroc Twice Daily + CBV (DB and OL) | 27 | 360 | |
| other | Anaemia | Blood and lymphatic system disorders | Efavirenz Once Daily + CBV (DB and OL) | 18 | 361 | |
| other | Anaemia | Blood and lymphatic system disorders | Maraviroc Twice Daily + CBV (SP) | 0 | 127 | |
| other | Conjunctivitis | Eye disorders | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | 11 | 174 | |
| other | Conjunctivitis | Eye disorders | Maraviroc Twice Daily + CBV (DB and OL) | 11 | 360 | |
| other | Conjunctivitis | Eye disorders | Efavirenz Once Daily + CBV (DB and OL) | 25 | 361 | |
| other | Conjunctivitis | Eye disorders | Maraviroc Twice Daily + CBV (SP) | 0 | 127 | |
| other | Abdominal distension | Gastrointestinal disorders | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | 12 | 174 | |
| other | Abdominal distension | Gastrointestinal disorders | Maraviroc Twice Daily + CBV (DB and OL) | 21 | 360 |
1 to 10 of 1,060Source ClinicalTrials.gov
See all 1,060 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | ||
| Total, all-cause mortality | Maraviroc Twice Daily + CBV (DB and OL) | ||
| Total, all-cause mortality | Efavirenz Once Daily + CBV (DB and OL) | ||
| Total, all-cause mortality | Maraviroc Twice Daily + CBV (SP) | ||
| Total, other adverse events | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | 151 | 174 |
| Total, other adverse events | Maraviroc Twice Daily + CBV (DB and OL) | 319 | 360 |
| Total, other adverse events | Efavirenz Once Daily + CBV (DB and OL) | 327 | 361 |
| Total, other adverse events | Maraviroc Twice Daily + CBV (SP) | 0 | 127 |
| Total, serious adverse events | Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) | 47 | 174 |
| Total, serious adverse events | Maraviroc Twice Daily + CBV (DB and OL) | 77 | 360 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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