Page last updated: 2024-10-16

adenine and HIV-Associated Lipodystrophy Syndrome

adenine has been researched along with HIV-Associated Lipodystrophy Syndrome in 21 studies

HIV-Associated Lipodystrophy Syndrome: Defective metabolism leading to fat maldistribution in patients infected with HIV. The etiology appears to be multifactorial and probably involves some combination of infection-induced alterations in metabolism, direct effects of antiretroviral therapy, and patient-related factors.

Research Excerpts

ExcerptRelevanceReference
"Differences in disease progression occurred from the third year on ART, whereas higher rates of switch to second-line treatment occurred in LCM from the second year."2.75Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial. ( Abaine, D; Aber, M; Ahimbisibwe, F; Akao, J; Akuma, S; Amuron, B; Amurwon, J; Angweng, E; Anywar, W; Atwiine, D; Atwiine, S; Awio, P; Babiker, A; Babiker, AG; Bafana, T; Bagaya, L; Bahendeka, S; Bakeinyaga, GT; Barungi, G; Bassett, M; Bohannon, J; Boocock, K; Borok, M; Bray, D; Breckenridge, A; Bulaya-Tembo, R; Buluma, E; Burke, A; Burke, C; Byakwaga, H; Byamukama, A; Byaruhanga, R; Chakonza, L; Chidziva, E; Chigwedere, E; Chimanzi, J; Chimbetete, C; Chirairo, H; Chirara, M; Chirema, O; Chitsungo, S; Chivhunga, T; Coutinho, A; Darbyshire, JH; Drasiku, A; Dunn, D; Enzama, R; Etukoit, B; Fadhiru, K; Ferrier, A; Florence, A; Foster, S; Gazzard, B; Generous, L; Gibb, DM; Gilks, C; Gilks, CF; Goodall, R; Grosskurth, H; Grundy, C; Haguma, W; Hakim, J; Hill, C; Hughes, P; Jamu, A; Jangano, M; Jones, S; Kabanda, J; Kabuye, G; Kagina, G; Kajungu, D; Kaleebu, P; Kambungu, A; Kankunda, R; Karungi, J; Kasirye, R; Katabira, E; Katabira, H; Katundu, P; Khauka, P; Kigozi, J; Kikaire, B; Kityo, C; Komugyena, J; Kulume, R; Kusiima, A; Kyomugisha, H; Labeja, O; Lara, AM; Latif, A; Levin, J; Lubwama, E; Lutwama, F; Lyagoba, F; Machingura, I; Machingura, J; Makota, S; Mambule, I; Mapinge, F; Mapuchere, C; Massa, R; Matenga, J; Matongo, M; Maweni, C; Mawora, A; McCormick, A; McLaren, A; Mdege, N; Moyo, K; Muchabaiwa, L; Mudzingwa, S; Mufuka-Kapuya, C; Muganzi, A; Mugisha, A; Mugurungi, O; Mugyenyi, P; Muhweezi, D; Muhwezi, A; Mukiibi, S; Mukose, A; Mulindwa, G; Mulindwa, M; Munderi, P; Murungi, S; Musana, H; Musoro, G; Mutowo, J; Mutsai, S; Muvirimi, C; Muyingo, S; Muzambi, M; Mwebesa, D; Mwesigwa, P; Nabankema, E; Nabongo, P; Naidoo, B; Nairuba, R; Nakahima, W; Nakazibwe, M; Nakiyingi, J; Nalumenya, R; Namale, L; Namara, W; Namata, I; Namazzi, A; Namuli, T; Namyalo, M; Nanfuka, A; Nanfuka, R; Nassuna, G; Ndembi, N; Newland, C; Ngorima, N; Nimwesiga, E; Nsibambi, D; Nyachwo, L; Nyiraguhirwa, D; Ochai, R; Ojiambo, H; Ojiambo, W; Oketta, F; Omony, W; Otim, T; Oyugi, J; Palfreeman, A; Pascoe, M; Pearce, G; Peto, L; Peto, T; Phiri, M; Pillay, D; Pozniak, A; Puddephatt, C; Rahim, S; Rauchenberger, M; Reid, A; Robertson, V; Ronald, A; Rooney, J; Ruberantwari, A; Rutikarayo, N; Sabiiti, J; Sadik, F; Sematala, F; Serwadda, D; Sheehan, S; Simango, M; Smith, M; Snowden, W; Spencer-Drake, C; Spyer, M; Ssali, F; Steens, JM; Svovanapasis, P; Takubwa, J; Taylor, K; Taziwa, F; Tinago, G; Todd, J; Tugume, S; Tukamushaba, J; Tumukunde, D; Tumusiime, C; Twijukye, C; Vere, L; Waita, R; Wakholi, BN; Walker, AS; Walusimbi, J; Wangati, K; Wanyama, J; Wapakhabulo, AC; Warambwa, C; Warara, R; Wavamunno, P; Weller, I; Whitworth, J; Wilkes, H; Winogron, D; Yirrell, D; Zalwango, A; Zalwango, E; Zawedde, C; Zengeza, E, 2010)
"The use of nucleoside analogues, especially that of thymidine analogues, depletes mitochondrial DNA, which is the cause of many of the adverse effects of this family of antiretroviral drugs, among them lipodystrophy."2.44[Tenofovir as a strategy to avoid or limit adverse effects]. ( Portilla, J, 2008)
" These data have now provided a clear and clinically relevant understanding of the individual profiles of drugs within the nucleoside analogue reverse transcriptase inhibitor , HIV protease inhibitor and non-nucleoside analogue reverse transcriptase inhibitor drug classes, and have provided a rational basis for assessing and monitoring these adverse effects in clinical practice."2.43Adverse effects of antiretroviral therapy for HIV infection: a review of selected topics. ( Mallal, S; Nolan, D; Reiss, P, 2005)
"Co-treatment with zidovudine plus lamivudine, or zidovudine plus lamivudine and abacavir, did not increase the effect of zidovudine on cell viability or apoptosis."1.32The HIV-1 nucleoside reverse transcriptase inhibitors stavudine and zidovudine alter adipocyte functions in vitro. ( Auclair, M; Capeau, J; Caron, M; Kornprobst, M; Lagathu, C; Lombès, A; Walker, UA, 2004)

Research

Studies (21)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's14 (66.67)29.6817
2010's7 (33.33)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Domingo, P1
Gutierrez, Mdel M1
Gallego-Escuredo, JM1
Torres, F1
Mateo, MG1
Villarroya, J1
Lamarca, K1
Domingo, JC1
Vidal, F1
Villarroya, F1
Giralt, M1
Zhou, X1
Yu, W1
Li, T1
Guo, F1
Lin, Q1
Shao, H1
Tian, J1
Xu, Y1
Sun, P1
van Griensven, J1
Zachariah, R1
Rasschaert, F1
Atté, EF1
Reid, T1
Portilla, J1
Miralles Alvarez, C1
Gerschenson, M3
Kim, C1
Berzins, B1
Taiwo, B1
Libutti, DE2
Choi, J2
Chen, D1
Weinstein, J1
Shore, J1
da Silva, B1
Belsey, E1
McComsey, GA3
Murphy, RL1
Ribera Pascuet, E1
Curran, A2
Benn, P1
Sauret-Jackson, V1
Cartledge, J2
Ruff, C1
Sabin, CA2
Moyle, G1
Linney, A1
Reilly, G3
Edwards, SG1
Fisher, M1
Moyle, GJ2
Shahmanesh, M2
Orkin, C1
Kingston, M1
Wilkins, E2
Ewan, J1
Liu, H1
Ebrahimi, R1
Mugyenyi, P3
Walker, AS2
Hakim, J3
Munderi, P2
Gibb, DM2
Kityo, C2
Reid, A2
Grosskurth, H3
Darbyshire, JH3
Ssali, F2
Bray, D2
Katabira, E3
Babiker, AG1
Gilks, CF1
Kabuye, G1
Nsibambi, D2
Kasirye, R1
Zalwango, E1
Nakazibwe, M1
Kikaire, B1
Nassuna, G1
Massa, R1
Fadhiru, K2
Namyalo, M1
Zalwango, A1
Generous, L1
Khauka, P2
Rutikarayo, N1
Nakahima, W1
Mugisha, A1
Todd, J1
Levin, J1
Muyingo, S1
Ruberantwari, A1
Kaleebu, P2
Yirrell, D2
Ndembi, N2
Lyagoba, F2
Hughes, P1
Aber, M1
Lara, AM2
Foster, S2
Amurwon, J2
Wakholi, BN2
Whitworth, J1
Wangati, K1
Amuron, B1
Kajungu, D1
Nakiyingi, J1
Omony, W1
Tumukunde, D1
Otim, T1
Kabanda, J1
Musana, H1
Akao, J1
Kyomugisha, H1
Byamukama, A1
Sabiiti, J1
Komugyena, J1
Wavamunno, P1
Mukiibi, S1
Drasiku, A1
Byaruhanga, R1
Labeja, O1
Katundu, P2
Tugume, S2
Awio, P1
Namazzi, A1
Bakeinyaga, GT1
Katabira, H1
Abaine, D1
Tukamushaba, J1
Anywar, W1
Ojiambo, W1
Angweng, E1
Murungi, S2
Haguma, W1
Atwiine, S1
Kigozi, J3
Namale, L1
Mukose, A1
Mulindwa, G1
Atwiine, D1
Muhwezi, A1
Nimwesiga, E1
Barungi, G1
Takubwa, J1
Mwebesa, D1
Kagina, G1
Mulindwa, M1
Ahimbisibwe, F1
Mwesigwa, P1
Akuma, S1
Zawedde, C1
Nyiraguhirwa, D1
Tumusiime, C1
Bagaya, L1
Namara, W1
Karungi, J1
Kankunda, R1
Enzama, R1
Latif, A2
Robertson, V2
Chidziva, E1
Bulaya-Tembo, R1
Musoro, G1
Taziwa, F1
Chimbetete, C1
Chakonza, L1
Mawora, A1
Muvirimi, C1
Tinago, G1
Svovanapasis, P1
Simango, M1
Chirema, O1
Machingura, J1
Mutsai, S1
Phiri, M1
Bafana, T1
Chirara, M2
Muchabaiwa, L2
Muzambi, M2
Mutowo, J1
Chivhunga, T1
Chigwedere, E1
Pascoe, M1
Warambwa, C1
Zengeza, E1
Mapinge, F1
Makota, S1
Jamu, A1
Ngorima, N1
Chirairo, H1
Chitsungo, S1
Chimanzi, J1
Maweni, C1
Warara, R1
Matongo, M1
Mudzingwa, S1
Jangano, M1
Moyo, K1
Vere, L1
Mdege, N1
Machingura, I1
Ronald, A1
Kambungu, A1
Lutwama, F1
Mambule, I1
Nanfuka, A1
Walusimbi, J1
Nabankema, E1
Nalumenya, R1
Namuli, T1
Kulume, R1
Namata, I1
Nyachwo, L1
Florence, A1
Kusiima, A1
Lubwama, E1
Nairuba, R1
Oketta, F1
Buluma, E1
Waita, R1
Ojiambo, H1
Sadik, F1
Wanyama, J1
Nabongo, P1
Oyugi, J1
Sematala, F1
Muganzi, A1
Twijukye, C1
Byakwaga, H1
Ochai, R1
Muhweezi, D1
Coutinho, A1
Etukoit, B1
Gilks, C2
Boocock, K1
Puddephatt, C1
Grundy, C1
Bohannon, J1
Winogron, D1
Burke, A1
Babiker, A2
Wilkes, H1
Rauchenberger, M1
Sheehan, S1
Spencer-Drake, C1
Taylor, K1
Spyer, M1
Ferrier, A1
Naidoo, B1
Dunn, D2
Goodall, R2
Peto, L1
Nanfuka, R1
Mufuka-Kapuya, C1
Pillay, D1
McCormick, A1
Weller, I1
Bahendeka, S1
Bassett, M1
Wapakhabulo, AC1
Gazzard, B1
Mapuchere, C1
Mugurungi, O1
Burke, C1
Jones, S1
Newland, C1
Pearce, G1
Rahim, S1
Rooney, J1
Smith, M1
Snowden, W1
Steens, JM1
Breckenridge, A1
McLaren, A1
Hill, C1
Matenga, J1
Pozniak, A1
Serwadda, D1
Peto, T1
Palfreeman, A1
Borok, M1
Boothby, M1
McGee, KC1
Tomlinson, JW1
Gathercole, LL1
McTernan, PG1
Shojaee-Moradie, F1
Umpleby, AM1
Nightingale, P1
O'Riordan, M2
Libutti, D1
Rowe, D1
Storer, N1
Harrill, D1
Cordery, DV1
Martin, A1
Amin, J1
Kelleher, AD1
Emery, S1
Cooper, DA1
Daar, ES1
Collier, AC1
Kosmiski, L1
Santana, JL1
Fichtenbaum, CJ1
Fink, H1
Sax, PE1
Ribera, E1
Larrousse, M1
Negredo, E1
Clotet, B1
Estrada, V1
Sanz, J1
Berenguer, J1
Rubio, R1
Pulido, F1
Ferrer, P1
Alvarez, ML1
Arterburn, S1
Martínez, E1
Nolan, D2
Mallal, S2
Caron, M1
Auclair, M1
Lagathu, C1
Lombès, A1
Walker, UA1
Kornprobst, M1
Capeau, J1
Reiss, P1
Johnson, M1
Churchill, D1
Hay, P1
Fakoya, A1
Murphy, M1
Scullard, G1
Leen, C1
Viganò, A1
Brambilla, P1
Cafarelli, L1
Giacomet, V1
Borgonovo, S1
Zamproni, I1
Zuccotti, G1
Mora, S1
Behrens, GM1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial[NCT00225082]12 participants (Actual)Observational2004-11-30Completed
A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus [NCT00323544]Phase 3220 participants Interventional2004-10-31Completed
Reversibility of Mitochondrial Toxicity in HIV Lipoatrophy[NCT00119379]Phase 250 participants (Actual)Interventional2005-04-30Completed
A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects[NCT00118898]Phase 31,864 participants (Actual)Interventional2005-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Fat mtDNA Content

Subcutaneous abdominal fat mitochondrial DNA (mtDNA) (NCT00119379)
Timeframe: Baseline to Week 48

Interventioncopies/cell (Median)
Uridine Supplementation-169
Switch to TDF321

Change in Hip Bone Mineral Density (BMD)

Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventionhip BMD, g/cm^2 (Median)
Uridine Supplementation0.45
Switch to TDF-3.3

Change in Limb Fat

Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventionlimb fat (kg) (Median)
Uridine Supplementation0.1
Switch to TDF0.4

Change in Lumbar Spine Bone Mineral Density (BMD)

Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventionlumbar spine BMD, g/cm^2 (Median)
Uridine Supplementation0.39
Switch to TDF0.0

Change in PBMC mtDNA

Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell (NCT00119379)
Timeframe: Baseline to Week 48

Interventioncopies/cell (Median)
Uridine Supplementation-24
Switch to TDF-52

Change in Trunk Fat

Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48

Interventiontrunk fat (kg) (Median)
Uridine Supplementation0.2
Switch to TDF0.7

Amount of Study Follow-up

Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks

InterventionWeeks (Median)
EFV, FTC/TDF, and Placebo ABC/3TC141.4
EFV, Placebo FTC/TDF, and ABC/3TC133.3
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC141.6
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC137.3

Number of Participants With a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC145
EFV, Placebo FTC/TDF, and ABC/3TC182
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC137
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC156

Number of Participants With Regimen Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC162
EFV, Placebo FTC/TDF, and ABC/3TC246
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC157
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC233

Number of Participants With Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC152
EFV, Placebo FTC/TDF, and ABC/3TC239
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC138
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC216

Number of Participants With Virologic Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC57
EFV, Placebo FTC/TDF, and ABC/3TC72
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC57
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC83

Number of Participants With Virologic Failure and Emergence of Major Resistance

Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC27
EFV, Placebo FTC/TDF, and ABC/3TC41
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC12

Change in CD4 Count (Cells/mm3) From Baseline

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionCells/mm3 (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC163220.5
EFV, Placebo FTC/TDF, and ABC/3TC188250.5
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC175251.5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC177.5250.3

Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC89
EFV, Placebo FTC/TDF, and ABC/3TC1011
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC54
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC87

Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC1413.5
EFV, Placebo FTC/TDF, and ABC/3TC2318
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC810
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2018

Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC2223
EFV, Placebo FTC/TDF, and ABC/3TC3533
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1114
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC3025

Change in Fasting Triglyceride Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC109
EFV, Placebo FTC/TDF, and ABC/3TC1514
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1411
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2433

Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7870
EFV, Placebo FTC/TDF, and ABC/3TC6458
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7973
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7366

Cumulative Probability of Not Experiencing Regimen Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7970
EFV, Placebo FTC/TDF, and ABC/3TC6454
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8073
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC6657

Cumulative Probability of Not Experiencing Treatment Modification

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC8073
EFV, Placebo FTC/TDF, and ABC/3TC6756
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8677
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7362

Cumulative Probability of Not Experiencing Virologic Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC9490
EFV, Placebo FTC/TDF, and ABC/3TC8885
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC9289
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC8883

Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.

"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.~http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm" (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionParticipants (Number)
DeathAIDS-defining illnessHIV-1 relatated event
EFV, FTC/TDF, and Placebo ABC/3TC61456
EFV, Placebo FTC/TDF, and ABC/3TC112561
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC62057
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC82363

Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <200 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <200 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415398379362
EFV, Placebo FTC/TDF, and ABC/3TC400377361342
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416391384368
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411372374346

The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <50 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <50 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415372379345
EFV, Placebo FTC/TDF, and ABC/3TC400346361328
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416348384345
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411322374317

Time From Randomization to Virologic Failure

Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to virologic failure10th percentile time to virologic failure
EFV, FTC/TDF, and Placebo ABC/3TC3696
EFV, Placebo FTC/TDF, and ABC/3TC2436
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC2484
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2436

Time From Treatment Dispensation to a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

,,,
InterventionWeeks (Number)
5th percentile time to a grade 3/4 safety event10th percentile time to a grade 3/4 safety event25th percentile time to a grade 3/4 safety event
EFV, FTC/TDF, and Placebo ABC/3TC2.67.959.3
EFV, Placebo FTC/TDF, and ABC/3TC1.32.016.0
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC3.08.181.4
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.33.944.4

Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to regimen failure10th percentile time to regimen failure25th percentile time to regimen failure
EFV, FTC/TDF, and Placebo ABC/3TC41672
EFV, Placebo FTC/TDF, and ABC/3TC4424
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC41684
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC4436

Time From Treatment Dispensation to Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to treatment modification10th percentile time to treatment modification25th percentile time to treatment modification
EFV, FTC/TDF, and Placebo ABC/3TC3.415.083.7
EFV, Placebo FTC/TDF, and ABC/3TC1.42.127.4
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7.924.9108.9
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.65.043.6

Reviews

6 reviews available for adenine and HIV-Associated Lipodystrophy Syndrome

ArticleYear
[Tenofovir as a strategy to avoid or limit adverse effects].
    Enfermedades infecciosas y microbiologia clinica, 2008, Volume: 26 Suppl 8

    Topics: Adenine; Anemia; Anti-HIV Agents; Antimetabolites; Clinical Trials as Topic; DNA, Mitochondrial; Dou

2008
[Are all analogue combinations equal?].
    Enfermedades infecciosas y microbiologia clinica, 2008, Volume: 26 Suppl 8

    Topics: Adenine; Anti-HIV Agents; Antimetabolites; Antiretroviral Therapy, Highly Active; Cardiovascular Dis

2008
[Current role of tenofovir in clinical medicine].
    Enfermedades infecciosas y microbiologia clinica, 2008, Volume: 26 Suppl 8

    Topics: Adenine; Anti-HIV Agents; Antimetabolites; Antiretroviral Therapy, Highly Active; Chemical and Drug

2008
Thymidine analogue-sparing highly active antiretroviral therapy (HAART).
    Journal of HIV therapy, 2003, Volume: 8, Issue:1

    Topics: Adenine; Antiretroviral Therapy, Highly Active; Clinical Trials as Topic; Dideoxynucleosides; Drug R

2003
Adverse effects of antiretroviral therapy for HIV infection: a review of selected topics.
    Expert opinion on drug safety, 2005, Volume: 4, Issue:2

    Topics: Adenine; Alkynes; Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Cardi

2005
Treatment options for lipodystrophy in HIV-positive patients.
    Expert opinion on pharmacotherapy, 2008, Volume: 9, Issue:1

    Topics: Adenine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Dideoxynucleosides; Health Behavior

2008

Trials

10 trials available for adenine and HIV-Associated Lipodystrophy Syndrome

ArticleYear
A 48-week study of fat molecular alterations in HIV naive patients starting tenofovir/emtricitabine with lopinavir/ritonavir or efavirenz.
    Journal of acquired immune deficiency syndromes (1999), 2014, Aug-15, Volume: 66, Issue:5

    Topics: Adenine; Alkynes; Anti-HIV Agents; Benzoxazines; Cyclopropanes; Deoxycytidine; Drug Therapy, Combina

2014
Improvements in cheek volume in lipoatrophic individuals switching away from thymidine nucleoside reverse transcriptase inhibitors.
    HIV medicine, 2009, Volume: 10, Issue:6

    Topics: Absorptiometry, Photon; Adenine; Adult; Aged; Body Composition; Cheek; Dideoxynucleosides; Female; H

2009
A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals.
    Journal of acquired immune deficiency syndromes (1999), 2009, Aug-15, Volume: 51, Issue:5

    Topics: Adenine; Adipose Tissue; Adult; Aged; Alkynes; Anti-HIV Agents; Benzoxazines; Cyclopropanes; Deoxycy

2009
Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial.
    Lancet (London, England), 2010, Jan-09, Volume: 375, Issue:9709

    Topics: Adenine; Adolescent; Adult; Africa; Aged; Anemia; Anti-Retroviral Agents; CD4 Lymphocyte Count; Crea

2010
Adipocyte differentiation, mitochondrial gene expression and fat distribution: differences between zidovudine and tenofovir after 6 months.
    Antiviral therapy, 2009, Volume: 14, Issue:8

    Topics: Adenine; Adipocytes; Adipose Tissue; Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Cell Differentia

2009
Mitochondrial function, inflammation, fat and bone in HIV lipoatrophy: randomized study of uridine supplementation or switch to tenofovir.
    Antiviral therapy, 2012, Volume: 17, Issue:2

    Topics: Adenine; Adipocytes; Adipose Tissue; Adult; Anti-HIV Agents; Apoptosis; Bone Density; DNA, Mitochond

2012
Changes in fat mitochondrial DNA and function in subjects randomized to abacavir-lamivudine or tenofovir DF-emtricitabine with atazanavir-ritonavir or efavirenz: AIDS Clinical Trials Group study A5224s, substudy of A5202.
    The Journal of infectious diseases, 2013, Feb-15, Volume: 207, Issue:4

    Topics: Adenine; Adipose Tissue; Adult; Alkynes; Anti-HIV Agents; Atazanavir Sulfate; Benzoxazines; Cyclopro

2013
Impact of switching from zidovudine/lamivudine to tenofovir/emtricitabine on lipoatrophy: the RECOMB study.
    HIV medicine, 2013, Volume: 14, Issue:6

    Topics: Absorptiometry, Photon; Adenine; Adipose Tissue; Adult; Anti-HIV Agents; Antiretroviral Therapy, Hig

2013
A randomized comparative trial of tenofovir DF or abacavir as replacement for a thymidine analogue in persons with lipoatrophy.
    AIDS (London, England), 2006, Oct-24, Volume: 20, Issue:16

    Topics: Adenine; Adult; Aged; Anti-HIV Agents; Biomarkers; Body Fat Distribution; Dideoxynucleosides; Female

2006
Normalization of fat accrual in lipoatrophic, HIV-infected children switched from stavudine to tenofovir and from protease inhibitor to efavirenz.
    Antiviral therapy, 2007, Volume: 12, Issue:3

    Topics: Absorptiometry, Photon; Adenine; Adolescent; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highl

2007

Other Studies

5 other studies available for adenine and HIV-Associated Lipodystrophy Syndrome

ArticleYear
[To evaluate the changes in body composition in male human immunodeficiency virus-related lipodystrophy after different treatment regimens by dual-energy X-ray absorptiometry].
    Zhonghua nei ke za zhi, 2014, Volume: 53, Issue:8

    Topics: Absorptiometry, Photon; Adenine; Anti-HIV Agents; Antiviral Agents; Body Composition; HIV Infections

2014
Weight evolution in HIV-1 infected women in Rwanda after stavudine substitution due to lipoatrophy: comparison of zidovudine with tenofovir/abacavir.
    Transactions of the Royal Society of Tropical Medicine and Hygiene, 2009, Volume: 103, Issue:6

    Topics: Adenine; Adult; Anti-HIV Agents; Body Weight; Dideoxynucleosides; Drug Therapy, Combination; Female;

2009
Mitochondrial function, morphology and metabolic parameters improve after switching from stavudine to a tenofovir-containing regimen.
    The Journal of antimicrobial chemotherapy, 2009, Volume: 63, Issue:6

    Topics: 8-Hydroxy-2'-Deoxyguanosine; Adenine; Adipose Tissue; Adult; Anti-HIV Agents; Body Fat Distribution;

2009
The influence of HLA supertype on thymidine analogue associated with low peripheral fat in HIV.
    AIDS (London, England), 2012, Nov-28, Volume: 26, Issue:18

    Topics: Adenine; Anti-HIV Agents; Australia; Biomarkers; Blood Glucose; Body Fat Distribution; CD4 Lymphocyt

2012
The HIV-1 nucleoside reverse transcriptase inhibitors stavudine and zidovudine alter adipocyte functions in vitro.
    AIDS (London, England), 2004, Nov-05, Volume: 18, Issue:16

    Topics: 3T3-L1 Cells; Adenine; Adipocytes; Animals; Apoptosis; Cell Differentiation; Didanosine; Dideoxynucl

2004